UNITUS 15ZB00102

GUDID 00196449008940

8Bx8Lx8R STERILE KIT

Tyber Medical, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00196449008940
• NIH Device Record Key: bc7e4e8b-faed-4fae-b8a3-975bd0562112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNITUS
• Version Model Number: 15ZB00102
• Catalog Number: 15ZB00102
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com
• Phone: +1(866)761-0933
• Email: nmerlini@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196449008940 [Primary]

FDA Product Code

• JDR: Staple, fixation, bone

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: 2025-08-15
• Device Publish Date: 2023-01-07

On-Brand Devices [UNITUS]

• 00196449009046: 30Bx20Lx20R STERILE KIT
• 00196449009039: 15Bx15Lx18R STERILE KIT
• 00196449009022: 10Bx13Lx15R STERILE KIT
• 00196449009015: 25Bx20Lx20R STERILE KIT
• 00196449009008: 20Bx20Lx20R STERILE KIT
• 00196449008995: 20Bx18Lx18R STERILE KIT
• 00196449008988: 18Bx18Lx18R STERILE KIT
• 00196449008971: 15Bx15Lx15R STERILE KIT
• 00196449008964: 15Bx12Lx12R STERILE KIT
• 00196449008957: 10Bx8Lx8R STERILE KIT
• 00196449008940: 8Bx8Lx8R STERILE KIT