N/A

GUDID M695M9402320

Tyber Medical, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: M695M9402320
• NIH Device Record Key: c17e6729-8657-4227-8a01-f12924dd83a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: M9-40232
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695M9402320 [Primary]

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-08-15
• Device Publish Date: 2019-02-06

Devices Manufactured by Tyber Medical, LLC

• 00196449008940 - UNITUS: 2025-08-15 8Bx8Lx8R STERILE KIT
• 00196449008957 - UNITUS: 2025-08-15 10Bx8Lx8R STERILE KIT
• 00196449008964 - UNITUS: 2025-08-15 15Bx12Lx12R STERILE KIT
• 00196449008971 - UNITUS: 2025-08-15 15Bx15Lx15R STERILE KIT
• 00196449008988 - UNITUS: 2025-08-15 18Bx18Lx18R STERILE KIT
• 00196449008995 - UNITUS: 2025-08-15 20Bx18Lx18R STERILE KIT
• 00196449009008 - UNITUS: 2025-08-15 20Bx20Lx20R STERILE KIT
• 00196449009015 - UNITUS: 2025-08-15 25Bx20Lx20R STERILE KIT