TEHLIN

Basic Information

• Brand Name: TEHLIN
• Primary DI: 04719883462909
• Version / Model: D-TWP-A2
• 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: 6f40ad57-41b9-4fe8-83b3-5d0538dd71fb

Device Description

AK WEDGE PLATE (ALUMINUM)

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: 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
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61229	External lower-limb prosthesis structural/alignment component	A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719883462909	GS1