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

• 00361554007229 - Gentell: 2025-09-03 GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm)
• 00361554007250 - Gentell: 2025-09-03 GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm)
• 00361554007182 - Gentell: 2025-09-03 GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm)
• 00361554003375 - Gentell: 2025-08-29 GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm)
• 00361554001098 - Gentell: 2025-08-29 GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm)
• 00361554001128 - Gentell: 2025-08-29 GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm)
• 15056860000072 - Gentell Hydrogel Sheet Dressing: 2025-08-29 GEN-11470 Gentell Hydrogel Sheet Dressing, 120mm x 86mm (4.7” x 3.4”), Borderless
• 15056860000089 - Gentell Hydrogel Sheet Dressing: 2025-08-29 GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless