DermaCol Healogics by Dermarite

GUDID 00714196933126

DERMARITE INDUSTRIES LLC

Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing Biochemically-interactive dressing

Primary Device ID	00714196933126
NIH Device Record Key	3bcb9988-5a4b-4ea6-a8d1-0ac2e0f3d863
Commercial Distribution Status	In Commercial Distribution
Brand Name	DermaCol Healogics by Dermarite
Version Model Number	93312
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	00714196933126 [Primary]
GS1	01714196933125 [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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-02-05
Device Publish Date	2020-01-28

On-Brand Devices [DermaCol Healogics by Dermarite]

00714196933126	93312
00714196933119	93311