Calcium Alginate Ag (Silver) Dressing (4x8 in) GEN-13482

GUDID 00361554000985

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00361554000985
• NIH Device Record Key: 2e37fd7b-f011-44ae-92e3-9e5cf0b3d9f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcium Alginate Ag (Silver) Dressing (4x8 in)
• Version Model Number: GEN-13482
• Catalog Number: GEN-13482
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• 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	00361554000961 [Unit of Use]
GS1	00361554000978 [Primary]
GS1	00361554000985 [Package]; Contains: 00361554000978; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120181

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2025-02-26
• Device Publish Date: 2025-02-18

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
• 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
• 00361554000985 - Calcium Alginate Ag (Silver) Dressing (4x8 in): 2025-02-26