ComfortFoam/Ag Border Healogics by DermaRite

GUDID 00714196932921

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 00714196932921
• NIH Device Record Key: e5dccb5e-42da-4179-8578-82038c7420ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfortFoam/Ag Border Healogics by DermaRite
• Version Model Number: 93292
• 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	00714196932921 [Primary]
GS1	01714196932920 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170077

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

Devices Manufactured by DERMARITE INDUSTRIES LLC

• 71419624712486 - DermaSyn: 2024-10-29
• 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