Loop-X Disposable Sterile Drape Set

GUDID 04056481142827

The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging device. The drape set creates a sterile barrier between the OR field and the imaging device, allowing intraoperative 2D imaging of patients in a sterile environment.

Brainlab AG

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• Primary Device ID: 04056481142827
• NIH Device Record Key: 1a298037-c977-4981-9026-43a3f342a893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loop-X Disposable Sterile Drape Set
• Version Model Number: 22183-01
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481142827 [Package]; Contains: 04056481143299; Package: [5 Units]; In Commercial Distribution
GS1	04056481143299 [Primary]

FDA Product Code

• PUI: Drape, Surgical, Exempt

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: 2021-10-20
• Device Publish Date: 2021-10-12

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