Silicone Sheeting Non-Reinforced

GUDID 10684995300115

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile
Primary Device ID10684995300115
NIH Device Record Key8df84d0d-4df3-4aec-a130-d3b8e2975c28
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Sheeting Non-Reinforced
Version Model NumberPR72034-24N
Company DUNS080524654
Company NameBENTEC MEDICAL OPCO, LLC
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100684995300118 [Unit of Use]
GS110684995300115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-10
Device Publish Date2017-01-11

On-Brand Devices [Silicone Sheeting Non-Reinforced]

00684995300309PR72034-10SPN
00684995300293PR72034-015SPN
00684995300286PR72034-03SPN
00684995300279PR72034-02SPN
00684995300262PR72034-01SPN
00684995300255PR72034-04SPN
00684995300248PR72034-12N
00684995300231PR72034-11N
00684995300224PR72034-10N
00684995300217PR72034-09N
00684995300200PR72034-08N
00684995300194PR72034-07N
00684995300187PR72034-06N
00684995300170PR72034-05N
00684995300163PR72034-04N
00684995300156PR72034-03N
00684995300149PR72034-02N
00684995300132PR72034-01N
00684995300125PR72034-00N
10684995300115PR72034-24N
10684995300108PR72034-23N
10684995300092PR72034-22N
10684995300085PR72034-21N
10684995300078PR72034-20N
10684995300061PR72034-54N
10684995300054PR72034-53N
10684995300047PR72034-52N
10684995300030PR72034-51N
10684995300023PR72034-64N
10684995300016PR72034-62N
10684995300009PR72034-66N

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