TEHLIN

Basic Information

• Brand Name: TEHLIN
• Primary DI: 04719883463531
• Version / Model: J-HT-010L
• 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: 2025-01-10
• Public Version: 1
• Public Version Date: 2025-01-20
• Public Version Status: New
• Public Device Record Key: 9714db03-b2db-497b-ae3b-aafc48a15964

Device Description

WRIST (LARGE)

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: No
• Has Lot/Batch Number: No
• 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
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41486	Partial-hand prosthesis	An artificial substitute for part of a missing hand designed to replace the appearance and/or some of the function of the hand part.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719883463531	GS1