FDA.reportPublic FDA data

Calcium Alginate Dressing Rope (12 in)

Primary DI
00361554002897
Brand
Calcium Alginate Dressing Rope (12 in)
Company
Gentell, LLC
Model
GEN-13120
Catalog number
GEN-13120
Published
2025-03-27
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
00361554002903PackageGS15In Commercial Distribution
00361554002897PrimaryGS10
00361554002880Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361554002903003615540029033615540029030361554002903
00361554002897003615540028973615540028970361554002897
00361554002880003615540028803615540028800361554002880

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.

Regulatory Flags#

DUNS number
170967876
Device count
10
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00361554001098GentellGEN-130402025-08-21
00361554001128GentellGEN-130602025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22