FDA.reportPublic FDA data

Gentell

Primary DI
00361554000787
Brand
Gentell
Company
Gentell, LLC
Model
GEN-18000
Catalog number
GEN-18000
Device description
Collagen Particles Wound Filler 1 gram Pouch
Published
2024-07-02
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
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232796000LUOFUCON® Collagen Particles (Collagen Wound Dressing)Huizhou Foryou Medical Devices Co., Ltd.2024-04-25KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00361554000794PackageGS150In Commercial Distribution
00361554000787PrimaryGS10
00361554000770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00361554000794003615540007943615540007940361554000794
00361554000787003615540007873615540007870361554000787
00361554000770003615540007703615540007700361554000770

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170967876
Device count
5
Lot or batch
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
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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00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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