Silicone Block

GUDID 00684995200135

Soft, 0.5'' x 1'' x 1''

BENTEC MEDICAL OPCO, LLC

Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material
Primary Device ID00684995200135
NIH Device Record Key17bd460d-1612-45f4-acc2-8cec85b3a1f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Block
Version Model NumberPR88032-221
Company DUNS080524654
Company NameBENTEC MEDICAL OPCO, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100684995200135 [Primary]

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

On-Brand Devices [Silicone Block]

00684995200159X-Firm, 0.5'' x 1'' x 1''
00684995200142Firm, 0.5'' x 1'' x 1''
00684995200135Soft, 0.5'' x 1'' x 1''

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