Austin A-AU-10-122S

GUDID 00850017635425

Mother’s Viewing Drape with Bleed ID Window

AUSTIN MEDICAL

Patient surgical drape, single-use

• Primary Device ID: 00850017635425
• NIH Device Record Key: 2350aef8-7254-4a81-8b9b-010663e66165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin
• Version Model Number: A-AU-10-122S
• Catalog Number: A-AU-10-122S
• 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	00850017635418 [Primary]
GS1	00850017635425 [Package]; Contains: 00850017635418; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

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: 2021-04-14
• Device Publish Date: 2021-04-06

On-Brand Devices [Austin]

• 00866001000346: Total Capture Hysteroscopy Drape
• 00850017635425: Mother’s Viewing Drape with Bleed ID Window