Austin Medical, Inc. AU-198S

GUDID 00850017635593

RCT-3 Arthrogram Procedure Tray

AUSTIN MEDICAL

General surgical procedure kit, medicated

• Primary Device ID: 00850017635593
• NIH Device Record Key: 026593ad-2f97-42de-ae37-a3143f58dfe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Austin Medical, Inc.
• Version Model Number: AU-198S
• Catalog Number: AU-198S
• Company DUNS: 010058700
• Company Name: AUSTIN MEDICAL
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017635593 [Primary]

FDA Product Code

• LRO: General Surgery Tray

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: 2025-11-26
• Device Publish Date: 2025-10-29

On-Brand Devices [Austin Medical, Inc. ]

• 00866001000360: Hemorrhage View C-section Drape
• 00850017635456: Protego Pro Kit
• 00850017635593: RCT-3 Arthrogram Procedure Tray