Silicone Sheeting Open Border

GUDID 00684995320055

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile
Primary Device ID00684995320055
NIH Device Record Keybfeefc27-be85-4f17-ba88-52b7b28d4348
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Sheeting Open Border
Version Model NumberPR72034-05
Company DUNS080524654
Company NameBENTEC MEDICAL OPCO, LLC
Device Count1
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
GS100684995320055 [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 Open Border]

00684995320079PR72034-007
00684995320062PR72034-06
00684995320055PR72034-05
00684995320048PR72034-04
00684995320031PR72034-03
00684995320024PR72034-02
00684995320017PR72034-015
00684995320000PR72034-01

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