FDA.reportPublic FDA data

Gentell

Primary DI
00361554001098
Brand
Gentell
Company
Gentell, LLC
Model
GEN-13040
Device description
GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm)
Published
2025-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
00361554001081PrimaryGS10
00361554001098Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361554001081003615540010813615540010810361554001081
00361554001098003615540010983615540010980361554001098

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170967876
Device count
10
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
00361554003870GentellGEN-158182024-11-29
00361554003818GentellGEN-154142024-11-29
00361554003412Silicone Superabsorbent Bordered Dressing GEN-196402026-05-19
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
00361554001128GentellGEN-130602025-08-21
15056860000072Gentell Hydrogel Sheet DressingGEN-114702025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22