DermaGinate/Ag

GUDID 00714196530127

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00714196530127
• NIH Device Record Key: a08b16bc-7d25-4c9a-98fd-04ec22c57842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaGinate/Ag
• Version Model Number: 00530E
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 5
• 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	00714196530127 [Primary]
GS1	01714196530126 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143335

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

On-Brand Devices [DermaGinate/Ag]

• 00714196935113: 93511
• 00714196535481: 00535E
• 00714196530127: 00530E
• 00714196525451: 00525E
• 00714196520227: 00520E
• 00714196392145: 00535E
• 00714196392121: 00530E
• 00714196392107: 00525E
• 00714196392084: 00520E