QARAM

Inactive Registered Visitor
#1
When someone asks for the Establishment Registration and Device Listing, what do you give them? Is any information on it confidential or should be kept private like the "D" numbers or the PIN?
 

MIREGMGR

Inactive Registered Visitor
#2
We regularly provide links to our Registration-and-Listing page in the public FDA database.

Listing numbers of course appear only in the internal/private FDA database, not the public version. Kit packers that export raw materials to a packing facility outside USA and then re-import the finished kits, in particular, are required as a part of an FDA PREDICT declaration at time of re-importation to state the Listing number of each kit component. PREDICT then automatically compares the declaration with the FDA databases to verify that all components are Listed in a manner that is consistent with their kit use. Thus if you sell to such kit packers, it's essentially obligatory that you provide Listing numbers.

The company for which I work has been doing so for years, and nothing bad has happened to us yet. Sometimes we just state them, sometimes we provide screen caps of the appropriate Listing detail page, depending on customer preference.

We would never ever disclose to anyone our PIN and PCN.
 

isoalchemist

Inactive Registered Visitor
#3
:2cents:Point them to Registration-and-Listing page in the public FDA database with your correct name. That part is all public record. Screen Caps also work well.

As MIREGMGR stated never give them your PIN and PCN, that would let them behind the public access door and cause problems
 
D

divineliving

#4
Hi! I saw your post and thought you may be able to help me... I am not a manufacturer, but rather a broker of pre-owned medical equipment which I buy from overstock in the USA and abroad, although all of it FDA approved.

I have not had any problems with the FDA in the past, but in this particular importation, the FDA is asking of the Device listing Number (D Number) and of course I don't have that, because I am not the manufacturer and as you stated, only the FDA and the manufacturer have this info?

What can I do? it is a rather substantial purchase and it is stuck with the FDA.. I had another shipment come in and they did not ask for this number, but rather just the 510K's which I have.
 

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