Austin Au-10-143S

GUDID 00866001000346

Total Capture Hysteroscopy Drape

AUSTIN MEDICAL

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00866001000346
• NIH Device Record Key: 1d74285e-e023-4e05-925b-ba686b23db4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin
• Version Model Number: Au-10-143S
• Catalog Number: Au-10-143S
• Company DUNS: 010058700
• Company Name: AUSTIN MEDICAL
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866001000339 [Primary]
GS1	00866001000346 [Package]; Contains: 00866001000339; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061422

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: 2018-07-09
• Device Publish Date: 2018-06-08

On-Brand Devices [Austin]

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