Calcium Alginate Ag (Silver) Dressing Rope (12 in)

Basic Information

• Brand Name: Calcium Alginate Ag (Silver) Dressing Rope (12 in)
• Primary DI: 00361554001036
• Version / Model: GEN-13142
• Catalog Number: GEN-13142
• Company Name: Gentell, LLC
• Labeler DUNS: 170967876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-02-18
• Public Version: 1
• Public Version Date: 2025-02-26
• Public Version Status: New
• Public Device Record Key: 80bd49e8-3546-4a20-854c-60f86a451d2f

Device Description

Calcium Alginate Ag (Silver) 12" Rope Dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00361554001043	GS1		5	In Commercial Distribution
Primary	00361554001036	GS1
Unit of Use	00361554001029	GS1

Premarket Submissions

Submission Number	Supplement Number
K120181	000