Uniglide Unicondylar Knee Prosthesis

Basic Information

• Brand Name: Uniglide Unicondylar Knee Prosthesis
• Primary DI: 05055196908901
• Version / Model: BC8J-4B03-000
• Catalog Number: BC8J-4B03-000
• Company Name: CORIN LTD
• Labeler DUNS: 295437313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 6
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 883a4a2d-f4fb-4b91-927f-b2cb622bd936

Device Description

SPHERICAL REAMER- SIZE 4

Device Characteristics

• Single Use: No
• 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: 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
HRY	PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055196908901	GS1

Customer Contacts

• Phone: [phone] ext. 2118
• Email: [email protected]
• Phone: [phone] ext. 2203
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K050764	000