Gentell Hydrogel Sheet Dressing

GUDID 15056860000089

GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless

Gentell, LLC

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 15056860000089
• NIH Device Record Key: f776b85c-a446-4465-8b2e-86e4bba95dde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentell Hydrogel Sheet Dressing
• Version Model Number: GEN-11700
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15056860000058 [Primary]
GS1	15056860000089 [Unit of Use]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-29
• Device Publish Date: 2025-08-21

On-Brand Devices [Gentell Hydrogel Sheet Dressing]

• 15056860000089: GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless
• 15056860000072: GEN-11470 Gentell Hydrogel Sheet Dressing, 120mm x 86mm (4.7” x 3.4”), Borderless