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

[somashekar]

Re: Finding Medical Device Listing Numbers on the FDA site

I am correcting myself. The listing number is not necessary. What I will need is the Establishment registration number who is importing the device into USA.

 

[MediMerchant]

Can anybody help me find the FDA medical device listing number for a Stryker CORE. I am trying to send the CORE from South Africa to the USA, where it was originally manufactured, and the device listing number is required to clear the CORE through customs.

 

[Ronen E]

AFAIK it's not publicly accessible, you'll have to get it from the manufacturer.

 

[Michael Malis]

Go to the FDA website and search "Establishment Registration and Medical Device Listing Files". Provide information in appropriate spots (location, company, product, etc.) and get registration number.

Or call Stryker office in NJ and tell them that you need listing number for CORE

 

[Al Rosen]

Can anybody help me find the FDA medical device listing number for a Stryker CORE. I am trying to send the CORE from South Africa to the USA, where it was originally manufactured, and the device listing number is required to clear the CORE through customs.

Look at the database located at Establishment Registration & Device Listing

 

[Ronen E]

This will only provide registration numbers, not listing numbers.

 

[Al Rosen]

This is the result of the search. Isn't the 510k no. circled the listing number?

 

[JeantheBigone]

Al, that is the clearance number, not the listing number.

The only way to find the listing number is to log into the FURLS account. That information is not publicly accessible.

Michael gave the best answer. If you are not the manufacturer, call Stryker and get hold of someone in their RA group who has access to the D-numbers.

 

[bordermed]

So what do we do if the manufacturer doesn't return our calls or provide information on the D-numbers? Would an FOIA request to the FDA work in that case?

 

[Ronen E]

A FOIA request might take 6 months...