Custom Cover

GUDID 10848340020114

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 10848340020114
• NIH Device Record Key: c2825ca6-02a8-4d35-9c0a-db8faf812d09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Cover
• Version Model Number: 08-CC141
• 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: false
• 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	00848340020117 [Primary]
GS1	10848340020114 [Package]; Contains: 00848340020117; Package: [25 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: true
• Device Is Sterile: false

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

[10848340020114]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [Custom Cover]

• 10848340009904: Disposable Equipment Cover
• 10848340005906: Disposable Equipment Cover
• 10848340008747: Disposable Equipment Cover
• 10848340005913: Disposable Equipment Cover
• 10848340005524: Non-Sterile
• 10848340002226: Disposable Equipment Cover
• 10848340002240: Disposable Equipment Cover
• 10848340002233: Auto. Pull Back Device
• 10848340020114: Disposable Equipment Cover
• 10848340002264: Disposable Equipment Cover
• 10848340002257: w/Closed End
• 10848340005487: Non-sterile
• 10848340005470: Non-Sterile
• 10848340020305: Non-sterile
• 10848340005500: Non-sterile