DermaCol/Ag Healogics by DermaRite

GUDID 00714196933522

DERMARITE INDUSTRIES LLC

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00714196933522
• NIH Device Record Key: 3a8754b9-3ed6-4059-a38d-2990019674a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaCol/Ag Healogics by DermaRite
• Version Model Number: 93352
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 10
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714196933522 [Primary]
GS1	01714196933521 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060804

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-01-28

Devices Manufactured by DERMARITE INDUSTRIES LLC

• 01714196500150 - SilvaKollagen Gel: 2023-10-12 Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial c
• 00714196390028 - AquaDerm: 2022-05-10
• 00714196391780 - DermaFilm thin with Border: 2021-09-20
• 00714196390004 - Adhesive Tape Remover Pads: 2021-09-17
• 00714196390042 - AquaDerm: 2021-09-17
• 00714196390066 - AquaRite Extra CMC: 2021-09-17
• 00714196390080 - AquaRite Extra CMC: 2021-09-17
• 00714196390103 - AquaRite Extra CMC: 2021-09-17