TIBURON 9195

GUDID 00630140027546

Head and Neck Pack

Cardinal Health 200, LLC

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00630140027546
• NIH Device Record Key: 4bb02e5a-e399-45b9-a281-5421af477e8b
• Commercial Distribution Discontinuation: 2020-11-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIBURON
• Version Model Number: 9195
• Catalog Number: 9195
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, LLC
• 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: 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	00630140027546 [Primary]

FDA Product Code

• LRO: General Surgery Tray

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

Devices Manufactured by Cardinal Health 200, LLC

• 50197106530311 - CARDINAL HEALTH: 2025-01-17 UNIVERSAL PLASTIC PACK
• 50197106641222 - CARDINAL HEALTH: 2025-01-17 ANTERIOR PELVIC REPAIR PACK
• 50197106684502 - CARDINAL HEALTH: 2025-01-17 ARTHROSCOPY 121 GENERAL PK
• 50197106727438 - CARDINAL HEALTH: 2025-01-17 BASIC VEIN ABLATION PACK
• 50197106765829 - CARDINAL HEALTH: 2025-01-17 GYN LAPAROSCOPY PACK
• 50197106767793 - CARDINAL HEALTH: 2025-01-17 HYBRID PACK
• 50197106791378 - CARDINAL HEALTH: 2025-01-17 LAPAROSCOPY PACK
• 50197106796151 - CARDINAL HEALTH: 2025-01-17 UMC VASCULAR PACK