Gentell

Basic Information

• Brand Name: Gentell
• Primary DI: 00361554000787
• Version / Model: GEN-18000
• Catalog Number: GEN-18000
• Company Name: Gentell, LLC
• Labeler DUNS: 170967876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-07-02
• Public Version: 4
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: 07682d05-0d71-4d82-bd5e-bb0083d606ca

Device Description

Collagen Particles Wound Filler 1 gram Pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00361554000787	GS1
Unit of Use	00361554000770	GS1
Package	00361554000794	GS1	case	50	In Commercial Distribution