n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551343425
• Version / Model: 28729KLT
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-23
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 4d684174-788d-4da0-8677-54fce9b7ab94

Device Description

Knee Laxity Tester

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44110	Joint laxity analyser, battery-powered	A battery-powered device used to measure the functioning of normal or abnormal joints (e.g., a knee) in order to evaluate the slackness and/or displacement in the motion of the joint (i.e., the joint laxity), usually by measuring ranges of motion, acceleration, or forces exerted upon the joint. It may be employed in the assessment of other characteristics of the joint, e.g., stability and/or anterior/posterior tibial displacement. This device is typically used for reconstructive surgery to evaluate and control joint laxity and stability of the knee and the length of the reconstructed ligaments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551343425	GS1