Calcium Alginate Ag (Silver) Dressing Rope (12 in) GEN-13142

GUDID 00361554001043

Calcium Alginate Ag (Silver) 12" Rope Dressing

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00361554001043
• NIH Device Record Key: 80bd49e8-3546-4a20-854c-60f86a451d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcium Alginate Ag (Silver) Dressing Rope (12 in)
• Version Model Number: GEN-13142
• Catalog Number: GEN-13142
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 10
• 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	00361554001029 [Unit of Use]
GS1	00361554001036 [Primary]
GS1	00361554001043 [Package]; Contains: 00361554001036; Package: [5 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

• 00361554002002 - Comfortell Composite Dressing (4x4 in: 2025-04-04
• 00361554002033 - Comfortell Composite Dressing (6x6 in): 2025-04-04
• 00361554002903 - Calcium Alginate Dressing Rope (12 in): 2025-04-04
• 00361554001678 - Dermatell Hydrocolloid (Non-Bordered) Wound Dressing (4x4 in): 2025-04-03
• 00361554001708 - Dermatell Hydrocolloid (Bordered) Wound Dressing (4x4 in): 2025-04-03
• 10361554001729 - Dermatell Hydrocolloid (Bordered) Wound Dressing (6x6 in): 2025-04-03
• 00361554002101 - Gentell FixTape (2x11 yards): 2025-04-03
• 00361554002125 - Gentell FixTape (4x11 yards): 2025-04-03