Silverlon Antimicrobial Adhesive Strip

Basic Information

• Brand Name: Silverlon Antimicrobial Adhesive Strip
• Primary DI: 00857278000191
• Version / Model: AS-6003
• Company Name: ARGENTUM MEDICAL, LLC
• Labeler DUNS: 091449079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 1
• Public Version Date: 2020-10-08
• Public Version Status: New
• Public Device Record Key: bea336a4-aefd-470c-8cf7-788665b7853d

Device Description

Adhesive Strips 3in x 1in (Box of 24). Bandage is not directly marked with UDI information. As well, the pouch size for the bandage does not have enough space for labeling.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10857278000198	GS1		24	In Commercial Distribution
Primary	00857278000191	GS1