SBS - The best value in QMS software

LOT or Serial Number Symbol not used when the information is contained in the UDI?

Q

QARA93

Registered
#1
#1
Dear all,

As the serial number or lot number is embedded in the UDI-PI, and is identifiable in the human readable section of the UDI (under "(11)" or" (10)"), is it necessary to also include the LOT or SN symbol in the product label (followed of course by the identifier)? Would it be justifiable to not include it if there are space limitations on the product label?


Thanks!
 
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
As long as you are selling the device in the US market, where UDI is recognised, I don't think you you need to include the serial/lot number as a separate symbol. The information contained in the device identifier fulfils the regulatory requirement of 21 CFR 801.

Shimon
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
S Requirements relating to Serial Number and Lot Number Other US Medical Device Regulations 6
O Simple process for providing Serial/Lot Numbering for our product Document Control Systems, Procedures, Forms and Templates 5
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
N AS9100 8.5.1 j) - Lot splitting - any loopholes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
I Lot or Batch definition for IVDs Imported Legacy Blogs 0
N IVD Lot Numbers and Expiration Dates - 21 CFR 809.10 Other US Medical Device Regulations 3
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V 'Representative' Sample of the Lot for a Continuous Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
M Lot Numbers of Plastic Disposables in an LDT (laboratory developed test) ISO 13485:2016 - Medical Device Quality Management Systems 6
M How to Mathemetically Derive the AQL Tables given Lot Sizes AQL - Acceptable Quality Level 5
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
R Why the FDA requests Lot Number in Testing Reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
U AQL, Lot Size vs Sampling Plans AQL - Acceptable Quality Level 8
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
V FDA regulatory requirement on the lot number convention for medical devices US Food and Drug Administration (FDA) 2
K Can I use ANSI/AQL for the Total Number of Containers for the entire Lot? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
H How to calculate the Lot Reject Rate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A How can a sample can give information about bad products in whole lot? Quality Manager and Management Related Issues 3
M Pipet tips of the same Lot Number have different expiration dates Quality Manager and Management Related Issues 6
L Regulatory Submittal During 3 Lot Sterilization Validation EU Medical Device Regulations 3
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
N Switch to 100% inspection when lot fails sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
G Calculating the Fraction Defective Confidence Interval for a Lot Statistical Analysis Tools, Techniques and SPC 2
S Samples for a Destructive Test included in a Lot Size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
E How to determine the Lot Size for the OQ Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Ronen E Matrixx Initiatives Recalls One Lot of Zicam? Extreme Congestion Relief Other Medical Device and Orthopedic Related Topics 0
C Changing the Sample Size of a Lot Statistical Analysis Tools, Techniques and SPC 8
J Expanding the c = 0 Small Lot Squeglia Table Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
R Sampling Plan for Wafer Inspection (Small Lot) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
P Certificate of Free Sales (CFS) - Need to attach to each lot of exported product? Other Medical Device Regulations World-Wide 2
C What's the sampling plan I need to inspect for each lot? AQL - Acceptable Quality Level 7
T Trouble Inputting a lot of Data into Minitab Using Minitab Software 5
R Where does 20% Lot Qualification Rule Come from? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B Customer Inspection Frequency and Rejection Level Criteria - Sample Lot Size AQL - Acceptable Quality Level 6
A Rationalizing the use Lot Sizes greater than the PQ runs used in Process Validations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Lot of Process Maps because of processes, sub-processes, activities? Process Maps, Process Mapping and Turtle Diagrams 12
A C=0 and Skip Lot Sampling Plan Relationship Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6

Similar threads

Top Bottom