Establishment registered as specification developer and foreign exporter only

#1
The factory shipped out some orders under prior paperwork using the device listing numbers from the establishment that's listed only as a spec developer and foreign exporter. There is no reference to the contract manufacturer.

I believe this will get flagged by PREDICT because my understanding is that we can't ship to the U.S. using the spec developer MDL numbers. Is this correct?

Structure:

1. Spec Developer and Foreign Exporter (Holder of all 510(k)s)
2. Contract Manufacturer 1
3. Contract Manufacturer 2
4. Contract Manufacturer 3

All paper work **should** be shipped under the contract manufacturer device listings, but for some reason it didn't happen.

Any help would be, as always, greatly appreciated!

:thanx:
 
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somashekar

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Super Moderator
#3
The factory shipped out some orders under prior paperwork using the device listing numbers from the establishment that's listed only as a spec developer and foreign exporter. There is no reference to the contract manufacturer.

I believe this will get flagged by PREDICT because my understanding is that we can't ship to the U.S. using the spec developer MDL numbers. Is this correct?

Structure:

1. Spec Developer and Foreign Exporter (Holder of all 510(k)s)
2. Contract Manufacturer 1
3. Contract Manufacturer 2
4. Contract Manufacturer 3

All paper work **should** be shipped under the contract manufacturer device listings, but for some reason it didn't happen.

Any help would be, as always, greatly appreciated!

:thanx:
Well, as you mention the error has happened, and the best course would be to inform your buyer and keep the correct paperwork made and sent across, with copies to your clearing and forwarding agents.
I hope the three CM's have the listing numbers which clearly indicates the shipped product.
 
#4
Thank you both very much. Our CMs have active device listings for all shipped products, so we'll trace back to the proper CM and provide corrected paperwork to all relevant parties.

:thanks:
 
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