Austin Medical

GUDID 00850017635487

Drape, Mobile Radiation Barrier

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850017635487
• NIH Device Record Key: 33a53faa-9acf-49ee-bde8-93d69a699117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin Medical
• Version Model Number: X800-0117
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017635487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

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: 2023-06-16
• Device Publish Date: 2023-06-08

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• 10850003355433: Tauro Towel, Double
• 10850003355426: Tauro Towel, Single
• 26975424192274: Hemorrhage View C-Section Drape, sterile
• 00850017635487: Drape, Mobile Radiation Barrier
• 10850017635460: Bag, L-Femoral