Austin Medical, Inc. A800-0310

GUDID 00850017635456

Protego Pro Kit

AUSTIN MEDICAL

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• Primary Device ID: 00850017635456
• NIH Device Record Key: 10bf9bdf-48fd-40b3-b534-81a2d1f72987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin Medical, Inc.
• Version Model Number: A800-0310
• Catalog Number: A800-0310
• Company DUNS: 010058700
• Company Name: AUSTIN MEDICAL
• 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	00850017635456 [Package]; Contains: 00866001000391; Package: Case [25 Units]; In Commercial Distribution
GS1	00866001000391 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-18
• Device Publish Date: 2022-01-05

On-Brand Devices [Austin Medical, Inc.]

• 00866001000360: Hemorrhage View C-section Drape
• 00850017635456: Protego Pro Kit