FDA.reportPublic FDA data

Silicone Superabsorbent Bordered Dressing

Primary DI
00361554003412
Brand
Silicone Superabsorbent Bordered Dressing
Company
Gentell, LLC
Model
GEN-19640
Device description
4” x 4” (10cm x 10cm) with 2” x 2” (5cm x 5cm) Pad
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20361554003416PackageGS150In Commercial Distribution
00361554003412PrimaryGS10
00361554003405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2036155400341620361554003416
00361554003412003615540034123615540034120361554003412
00361554003405003615540034053615540034050361554003405

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
170967876
Device count
10
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
00361554003870GentellGEN-158182024-11-29
00361554003818GentellGEN-154142024-11-29
00361554003436Silicone Superabsorbent Bordered Dressing GEN-196602026-05-19
00361554003450Silicone Superabsorbent Bordered Dressing GEN-196802026-05-19
00361554007212GentellGEN-130222025-08-26
00361554007243GentellGEN-130442025-08-26
00361554007274GentellGEN-130662025-08-26
00361554007229GentellGEN-130222025-08-26
00361554007250GentellGEN-130442025-08-26
00361554007182GentellGEN-130662025-08-26
15056860000034Gentell Hydrogel Sheet DressingGEN-112402025-08-21
15056860000041Gentell Hydrogel Sheet DressingGEN-114702025-08-21
15056860000058Gentell Hydrogel Sheet DressingGEN-117002025-08-21
00361554001050GentellGEN-130202025-08-21
00361554001081GentellGEN-130402025-08-21
00361554001111GentellGEN-130602025-08-21
00361554003375GentellGEN-130202025-08-21
00361554001098GentellGEN-130402025-08-21
00361554001128GentellGEN-130602025-08-21
15056860000072Gentell Hydrogel Sheet DressingGEN-114702025-08-21

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