Silver-sept Silver Antimicrobial Skin and Wound Gel 3015S

GUDID 00367180312157

Silver-sept® 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.

ANACAPA TECHNOLOGIES, INC.

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• Primary Device ID: 00367180312157
• NIH Device Record Key: 33255a1b-2dc5-4b81-b821-5165d382dd09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silver-sept Silver Antimicrobial Skin and Wound Gel
• Version Model Number: 3015S
• Catalog Number: 3015S
• Company DUNS: 073189370
• Company Name: ANACAPA TECHNOLOGIES, INC.
• Device Count: 1
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net
• Phone: 9093947795
• Email: anacapa@anacapa-tech.net

Device Dimensions

• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram
• Weight: 43 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00367180300154 [Primary]
GS1	00367180312157 [Package]; Contains: 00367180300154; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062212

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [Silver-sept Silver Antimicrobial Skin and Wound Gel]

• 00367180300031: Silver-sept® Silver Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a
• 00367180312157: Silver-sept® Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear a