Silver-sept Silver Antimicrobial Skin and Wound Gel

Basic Information

• Brand Name: Silver-sept Silver Antimicrobial Skin and Wound Gel
• Primary DI: 00367180300031
• Version / Model: 3003S
• Catalog Number: 3003S
• Company Name: ANACAPA TECHNOLOGIES, INC.
• Labeler DUNS: 073189370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-22
• Public Version: 1
• Public Version Date: 2020-10-30
• Public Version Status: New
• Public Device Record Key: a5087285-0702-49e1-a55a-3e1932867083

Device Description

Silver-sept® Silver Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00367180300031	GS1
Package	00367180312034	GS1	Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062212	000

Device Sizes

Type	Value	Unit	Text
Weight	86	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius