Super Absorbent Dressing (8 x 8 in) GEN-19380

GUDID 10361554003495

Gentell, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial

• Primary Device ID: 10361554003495
• NIH Device Record Key: 4a0eb927-e95d-4ace-948e-44ed7c5e1be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Absorbent Dressing (8 x 8 in)
• Version Model Number: GEN-19380
• Catalog Number: GEN-19380
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 10
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00361554003481 [Unit of Use]
GS1	00361554003498 [Primary]
GS1	10361554003495 [Package]; Contains: 00361554003498; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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: 2025-02-28
• Device Publish Date: 2025-02-20

Devices Manufactured by Gentell, LLC

• 10361554001279 - Super Absorbent Adherent Dressing (8x8 in): 2025-02-28
• 10361554003259 - Super Absorbent Adherent Dressing (2x2 in): 2025-02-28
• 00361554003399 - Super Absorbent Dressing (2x2 in): 2025-02-28
• 10361554003464 - Super Absorbent Dressing (4x4 in): 2025-02-28
• 10361554003495 - Super Absorbent Dressing (8 x 8 in): 2025-02-28
• 10361554003495 - Super Absorbent Dressing (8 x 8 in): 2025-02-28
• 10361554003501 - Super Absorbent Adherent Dressing (5x5 in): 2025-02-28
• 10361554005420 - Super Absorbent Dressing 6" x 6": 2025-02-28
• 00361554000985 - Calcium Alginate Ag (Silver) Dressing (4x8 in): 2025-02-26