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Class II Medical Device UDI (Unique Device Identification) Question(s)

B

bobrob

#1
#1
We are a small medical device manufacturer with approximately 30 Class II products. We have signed up with GS1 and created our GUDID account. My question is pretty simple...

Where and how do I create the DI?

Thanks in advance!

BR
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hi,

The DI is the prefix you receive from GS1 + an ordinal number that is made up of the remaining digits in the GTIN. You need to maintain a look-up table that matches those ordinal numbers with your company's product codes (PN etc.).

HTH
Ronen.
 
rob73

rob73

looking for answers
#3
#3
GS1 will allow you to create and download you GTIN (DI) via their website. As Ronen says the GTIN is made up of your company prefix (8 digits) then five numbers. GS1 have loads of resources on their website which explain this and the allocation rules .
 
S

SteveK

#4
#4
The actual GTIN (Application Identifier = (01)) for the barcode starts with a digit in front of the allocated GS1 number i.e. is 14 digits. Typically 0, but could be any integer. Look at the GUDID site:

https://accessgudid.nlm.nih.gov/

For example a Laerdal Paediatric Pocket Mask, the GTIN (primary ID number) is 07045430075559.

Steve
 
C

Chrisx

Involved In Discussions
#5
#5
GS1 has web based software called "data hub". It used to be called "data driver". You use this software to assign GTINs to your part numbers. It includes an excel upload/download tool.
 
J

Jeffers

#6
#6
Why did you decide to utilize GS1? Does anyone have a compelling reason for choosing a particular accredited issuing agency (GS1, HIBCC, or ICCBBA).

I represent a small medical device manufacturer with fewer than 10 unique products.
I asked another manufacturer in a similar position about his choice, and he is using HIBCC. He justified this decision because they charge about $1000 as a one time fee, and he can create unlimited UDI's. Does anyone else have a reason why they have chosen to work with a particular agency?

Thank you in advance.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#7
#7
Jeffers said:
Why did you decide to utilize GS1? Does anyone have a compelling reason for choosing a particular accredited issuing agency (GS1, HIBCC, or ICCBBA).

I represent a small medical device manufacturer with fewer than 10 unique products.
I asked another manufacturer in a similar position about his choice, and he is using HIBCC. He justified this decision because they charge about $1000 as a one time fee, and he can create unlimited UDI's. Does anyone else have a reason why they have chosen to work with a particular agency?

Thank you in advance.
Click to expand...
If you search Elsmar for "GS1" you'll find some threads discussing that question.

Cheers,
Ronen.
 
C

ciclozan

Starting to get Involved
#8
#8
Hi,

Can someone provide me with an example SOP/template regarding the UDI implementation? Anybody updated their SOPs such as the Complaint Procedure, MDR, Labeling, Post Market Surveillance, etc?

Thank you,
 
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