Cannulated Screw System +

Basic Information

• Brand Name: Cannulated Screw System +
• Primary DI: 00810040681691
• Version / Model: 04.353.905.05
• Catalog Number: 04.353.905.05
• Company Name: Tyber Medical LLC
• Labeler DUNS: 010968002
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-05-09
• Public Version: 5
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 9352849d-d092-403a-bd73-d3b8dacf8959

Device Description

WASHER FOR 4.5 CANN SCREW + 5PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810040681691	GS1
Unit of Use	00810040684418	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]