Sterile Cover for Straumann® Falcon

GUDID 10848340019880

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use

• Primary Device ID: 10848340019880
• NIH Device Record Key: fdcff0e5-d678-4fc1-b17b-94e865117e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Cover for Straumann® Falcon
• Version Model Number: FA1150
• 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	00848340019883 [Primary]
GS1	10848340019880 [Package]; Contains: 00848340019883; 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: true

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

[10848340019880]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-08
• Device Publish Date: 2024-01-31

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