TEHLIN

Basic Information

• Brand Name: TEHLIN
• Primary DI: 04719883460004
• Version / Model: A-TGH-01
• Company Name: TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
• Labeler DUNS: 657485074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-31
• Public Version: 1
• Public Version Date: 2023-11-08
• Public Version Status: New
• Public Device Record Key: 1ccaa315-9cd6-4d8a-9bda-7c071494f885

Device Description

GRAPH-LITE HIP JOINT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISY	Joint, Knee, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64718	Mechanical-resistance external knee prosthesis	A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for device stance/swing control is based on media-free mechanical resistance (i.e., mechanical friction/spring-actuation with no fluid or gas operating media). The device may have various designs and functional features (e.g., hinge-type, spring-control, monocentric or polycentric, semi-automatic or manual lock/brake) for support during a variety of activities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719883460004	GS1