FDA.reportPublic FDA data

Silicone Sheeting, Reinforced

Primary DI
00684995310261
Brand
Silicone Sheeting, Reinforced
Company
BENTEC MEDICAL OPCO, LLC
Model
PR72034-015SPR
Device description
"0.015"" x 12"" x 14"""
Published
2023-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684995310261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684995310261006849953102616849953102610684995310261

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-sheet tissue reconstructive material, sterileA sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive otorhinolaryngology/head and neck surgery applications (e.g., repair of nasal septums, perforated eardrums).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080524654
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00684995300316Silicone Sheeting, Non-ReinforcedPR72034-60N2023-10-20
10684995300009Silicone Sheeting Non-ReinforcedPR72034-66N2017-01-11
10684995300016Silicone Sheeting Non-ReinforcedPR72034-62N2017-01-11
10684995300023Silicone Sheeting Non-ReinforcedPR72034-64N2017-01-11
10684995300030Silicone Sheeting Non-ReinforcedPR72034-51N2017-01-11
10684995300047Silicone Sheeting Non-ReinforcedPR72034-52N2017-01-11
10684995300054Silicone Sheeting Non-ReinforcedPR72034-53N2017-01-11
10684995300061Silicone Sheeting Non-ReinforcedPR72034-54N2017-01-11
10684995300078Silicone Sheeting Non-ReinforcedPR72034-20N2017-01-11
10684995300085Silicone Sheeting Non-ReinforcedPR72034-21N2017-01-11
10684995300092Silicone Sheeting Non-ReinforcedPR72034-22N2017-01-11
10684995300108Silicone Sheeting Non-ReinforcedPR72034-23N2017-01-11
10684995300115Silicone Sheeting Non-ReinforcedPR72034-24N2017-01-11
10684995310008Silicone Sheeting ReinforcedPR72034-51R2017-01-11
10684995310015Silicone Sheeting ReinforcedPR72034-52R2017-01-11
10684995310022Silicone Sheeting ReinforcedPR72034-53R2017-01-11
10684995310039Silicone Sheeting ReinforcedPR72034-54R2017-01-11
10684995310046Silicone Sheeting ReinforcedPR72034-55R2017-01-11
10684995310169Silicone Sheeting ReinforcedPR72034-60R2017-01-11
10684995310176Silicone Sheeting ReinforcedPR72034-63R2017-01-11

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Primary DI, Brand, Company table
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00850087488402CeeportCEEPORT INC.NAD2026-05-29
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10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
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10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
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