Disposable Equipment Cover

GUDID 10848340014878

Light Handle Cover

ADVANCE MEDICAL DESIGNS, INC.

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• Primary Device ID: 10848340014878
• NIH Device Record Key: 0c29a10f-5243-4283-9571-89f99c086a2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Equipment Cover
• Version Model Number: LKAV2NS
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• 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	00848340014871 [Primary]
GS1	10848340014878 [Package]; Contains: 00848340014871; Package: [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850959

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-04
• Device Publish Date: 2022-10-27

On-Brand Devices [Disposable Equipment Cover]

• 10848340005449: Synthes Fluid Warmer Drape
• 10848340014878: Light Handle Cover
• 10848340015431: Custom Drape Sheet
• 10848340015417: Drape Sheet