K2M Light Adapter-Wolf

Basic Information

• Brand Name: K2M Light Adapter-Wolf
• Primary DI: 00812432021344
• Version / Model: 011903
• Catalog Number: AC01-90054
• Company Name: LUMITEX, INC.
• Labeler DUNS: 108631797
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-14
• Public Version: 1
• Public Version Date: 2022-02-22
• Public Version Status: New
• Public Device Record Key: 283ba942-791b-43c6-9f58-25b2e780874c

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: Yes
• 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: 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
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	876.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812432021344	GS1