Gentell Hydrogel Sheet Dressing

Basic Information

• Brand Name: Gentell Hydrogel Sheet Dressing
• Primary DI: 15056860000034
• Version / Model: GEN-11240
• Company Name: Gentell, LLC
• Labeler DUNS: 170967876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-08-21
• Public Version: 1
• Public Version Date: 2025-08-29
• Public Version Status: New
• Public Device Record Key: e5b556eb-2a9b-4fe4-875c-6dc3492f8a97

Device Description

GEN-11240 Gentell Hydrogel Sheet Dressing, 60mm x 60mm (2.4” x 2.4”), Borderless

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	15056860000065	GS1
Primary	15056860000034	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius