SuperCable® ISO-Elastic™ Cerclage System

Basic Information

• Brand Name: SuperCable® ISO-Elastic™ Cerclage System
• Primary DI: 00818720013312
• Version / Model: 35-880-1060
• Catalog Number: 35-880-1060
• Company Name: Kinamed, Inc.
• Labeler DUNS: 184896645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-03
• Public Version: 1
• Public Version Date: 2022-10-11
• Public Version Status: New
• Public Device Record Key: e806698b-e484-4e80-bb92-8786721dbfa1

Device Description

TalonPasser™, Small, 60mm

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
63560	Wire/ligature passer, single-use	A sterile, hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818720013312	GS1