STRIDE Unicondylar Knee

Basic Information

• Brand Name: STRIDE Unicondylar Knee
• Primary DI: 00841153100366
• Version / Model: 110059
• Company Name: BLUE BELT TECHNOLOGIES, INC.
• Labeler DUNS: 015299627
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a4409884-d85b-41c8-ae8d-7d2f64cba564
• Distribution End Date: 2016-12-16

Device Description

STRIDE Tibial Insert Implant SIZE E, 8 mm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841153100366	GS1

Customer Contacts

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