K-WIRE 0.8 X 120MM

Basic Information

• Brand Name: K-WIRE 0.8 X 120MM
• Primary DI: 00888480429418
• Version / Model: BR101DTS
• Catalog Number: BR101DTS
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 53d55b2c-7132-4931-b26d-30fa03c73350

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
35684	Haemodialysis system blood line clamp	An electrically-powered integral unit of a haemodialysis system used to modify or stop the flow of blood through the blood line tubing during dialysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888480429418	GS1
Unit of Use	70888480429417	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092670	000