Silicone Sheeting Reinforced

GUDID 10684995310008

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile
Primary Device ID10684995310008
NIH Device Record Keyd5f25f19-60dd-4fc8-a506-be22f7a297bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Sheeting Reinforced
Version Model NumberPR72034-51R
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
GS100684995310001 [Unit of Use]
GS110684995310008 [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 Reinforced]

00684995310322PR72034-15SPR
00684995310315PR72034-04SPR
00684995310308PR72034-03SPR
00684995310292PR72034-02SPR
00684995310285PR72034-010SPR
00684995310278PR72034-01SPR
00684995310254PR72034-44R
00684995310247PR72034-43R
00684995310230PR72034-42R
00684995310223PR72034-41R
00684995310216PR72034-407R
00684995310209PR72034-14R
00684995310155PR72034-12R
00684995310148PR72034-10R
00684995310131PR72034-08R
00684995310124PR72034-07R
00684995310117PR72034-06R
00684995310100PR72034-05R
00684995310094PR72034-04R
00684995310087PR72034-03R
00684995310070PR72034-02R
00684995310063PR72034-01R
00684995310056PR72034-007R
10684995310268PR72034-07SPR
10684995310190PR72034-62R
10684995310183PR72034-64R
10684995310176PR72034-63R
10684995310169PR72034-60R
10684995310046PR72034-55R
10684995310039PR72034-54R
10684995310022PR72034-53R
10684995310015PR72034-52R
10684995310008PR72034-51R

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