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Finding Medical Device Listing Numbers on the USA's FDA site
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Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
Finding Medical Device Listing Numbers on the USA's FDA site
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Finding Medical Device Listing Numbers on the USA's FDA site


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Some Related Topic Tags
drlm (fda's device registration and listing module), fda (food and drug administration), fda classification, furls (fda's electronic registration and listing system), medical device listing codes and classifications, predict (usa's fda import information system), medical devices
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  Post Number #1  
Old 3rd December 2009, 01:15 PM
Exact

 
 
Total Posts: 1
Question Finding Medical Device Listing Numbers on the USA's FDA site

Can anyone tell me where to find a specific Medical Device Listing Number on the FDA site? I can find all of the classifications and reulations, but am unable to look up or find a specific device listing number. Thanks.

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  Post Number #2  
Old 3rd December 2009, 01:50 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Finding Medical Device Listing Numbers on the FDA site

The FDA has two device databases: a public one that's accessible via their website and includes a table of listed products but not the listing information itself or listing numbers, and a secured one that contains that listing information and numbers, and is where that information is entered and may be edited.

Listing numbers are not publically available from the FDA.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #3  
Old 8th December 2009, 03:20 PM
MikeEmergo - 2010

 
 
Total Posts: 17
Re: Finding Medical Device Listing Numbers on the FDA site

Go here

http://www.accessdata.fda.gov/script.../cfPMN/pmn.cfm

Lookup by company name. It will list the 3 digit fda code and some basic info..


Mike Johnson

Last edited by CarolX; 8th December 2009 at 03:23 PM. Reason: removed company name - belongs in user profile
  Post Number #4  
Old 10th December 2009, 07:19 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Finding Medical Device Listing Numbers on the FDA site

That works for tracking down the K or Approval number. I think the specific request above was for the Listing number, which would be the D or E number in the DRLM database. We get those requests occasionally...I think there's a Department of Commerce form somewhere that requires D/E numbers, even though no one knows them but the Manufacturer.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #5  
Old 16th December 2009, 12:34 PM
Michael Malis's Avatar
Michael Malis

 
 
Total Posts: 310
Re: Finding Medical Device Listing Numbers on the FDA site

Do you need GMDN codes?

if yes - List of Global Medical Device Nomenclature (GMDN) Codes
Thanks to Michael Malis for your informative Post and/or Attachment!
  Post Number #6  
Old 22nd April 2012, 07:07 AM
yana prus's Avatar
yana prus

 
 
Total Posts: 147
Re: Finding Medical Device Listing Numbers on the FDA site

MIREGMGR, I agree with you regarding the listing number form and it's location. Recently I'm getting more and more such requests from USA customs. Listing number is assigned by CDRH during the initial listing of the device in the DRLM website. There might be a few listing numbers for the medical device system system - one for the main component, and some for the other components and accessories.
In the recent letter to the industry about import entry review process from March 24, 2011,
http://www.fda.gov/MedicalDevices/Re.../ucm248321.htm
it clearly states that listing number is the type of information that must be provided/transmitted electronically to the United States Customs and Border Protection (CBP) when an imported product arrives in the US. Therefore foreign manufacturers should be familiar with their listing numbers and need to mention it on the Affirmation of Compliance Statement for the products they export to USA.
Thank You to yana prus for your informative Post and/or Attachment!
  Post Number #7  
Old 22nd April 2012, 04:30 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Finding Medical Device Listing Numbers on the FDA site

Yes, since my earlier post the FDA has introduced the PREDICT import-information system. In many cases, FDA border offices want screenshots of DRLM listing pages...not just the textual information...with the PREDICT filing.

That essentially makes it impossible to import medical devices into the US using older information that the importer might have on file, without the regulatorily responsible Manufacturer's current participation.

I've made one or two other posts here recently with more specific information on how PREDICT actually works, based on our interactions with FDA Maryland, FDA Dallas and the El Paso border office, and several large kit packers.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #8  
Old 1st July 2016, 09:59 AM
baseball2k2k

 
 
Total Posts: 6
Re: Finding Medical Device Listing Numbers on the FDA site

Thanks for the Link!
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