Aurix Wound Dressing Kit

GUDID 10852714003108

Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02

NUO THERAPEUTICS INC

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• Primary Device ID: 10852714003108
• NIH Device Record Key: bed56e2a-a426-4ea3-93bc-6ba265866456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurix Wound Dressing Kit
• Version Model Number: AGSW-02
• Company DUNS: 132418851
• Company Name: NUO THERAPEUTICS INC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10852714003108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060007

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-11-01
• Device Publish Date: 2016-09-30

On-Brand Devices [Aurix Wound Dressing Kit]

• 00852714003101: Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02
• 10852714003108: Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02