LOSPA IS Spinal System

Basic Information

• Brand Name: LOSPA IS Spinal System
• Primary DI: 08800068943439
• Version / Model: 217100051
• Company Name: Corentec Co., Ltd
• Labeler DUNS: 688739895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 1
• Public Version Date: 2022-10-31
• Public Version Status: New
• Public Device Record Key: 870e9b69-2ae8-4fd4-9e62-9f70b7c6f9c9

Device Description

Distraction blade,right,120mm

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
49774	Human herpesvirus 7 (HHV7) antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Human herpesvirus 7 (HHV7) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800068943439	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]