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

somashekar

Staff member
Super Moderator
#11
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.
 
Elsmar Forum Sponsor
#12
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.
 

Michael Malis

Quite Involved in Discussions
#14
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
 

JeantheBigone

Quite Involved in Discussions
#18
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.
 
#19
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?
 
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