Specials

Basic Information

• Brand Name: Specials
• Primary DI: 10889981283483
• Version / Model: SR-0732
• Catalog Number: SR-0732
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Labeler DUNS: 079840876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-14
• Public Version: 1
• Public Version Date: 2021-09-22
• Public Version Status: New
• Public Device Record Key: f55177a8-e69a-41d9-8ab1-89106827e978

Device Description

Counter Torque - Extended Tab Midline

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: No
• 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
47754	Infrared tissue coagulation system	An assembly of electrically-powered devices designed to produce infrared (IR) light used to heat blood vessels and soft tissues for haemostasis and/or tissue removal. It typically consists of a control unit, a handpiece, light guides, and contact tips. It may be used to stop bleeding, to remove superficial lesions (e.g., haemorrhoids, benign vaginal lesions, warts, tattoos), for tonsillectomy/adenotomy blood staunching, and to treat parenchymal or dental bleeding. The use of IR light helps to avoid/mimimize some adverse outcomes associated with the application of direct electrical current (e.g., electrode-tissue adhesions).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889981283483	GS1

Customer Contacts

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