FDA.reportPublic FDA data

Silicone Sheeting, Non-Reinforced

Primary DI
10684995300313
Brand
Silicone Sheeting, Non-Reinforced
Company
BENTEC MEDICAL OPCO, LLC
Model
PR72034-60N
Device description
0.005'' x 2'' x 2''
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10684995300313PackageGS12In Commercial Distribution
00684995300316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068499530031310684995300313
00684995300316006849953003166849953003160684995300316

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00684995300316Silicone Sheeting, Non-ReinforcedPR72034-60N2023-10-20
00684995310261Silicone Sheeting, ReinforcedPR72034-015SPR2023-10-20
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

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