Silvakollagen Gel

GUDID 00860008336217

Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/

The Hymed Group Corporation

Collagen wound matrix dressing

• Primary Device ID: 00860008336217
• NIH Device Record Key: 6e235334-b341-40a4-85c8-d5d209b9ac51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silvakollagen Gel
• Version Model Number: 00500
• Company DUNS: 926634791
• Company Name: The Hymed Group Corporation
• 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: false
• Single Use: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com
• Phone: 1-800-337-6296
• Email: customerservice@dermarite.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008336200 [Primary]
GS1	00860008336217 [Package]; Contains: 00860008336200; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132891

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: 2023-03-01
• Device Publish Date: 2023-02-21