SuperCable® Iso-Elastic™ Cerclage System

Basic Information

• Brand Name: SuperCable® Iso-Elastic™ Cerclage System
• Primary DI: 00898142001357
• Version / Model: 35-100-1010
• Catalog Number: 35-100-1010
• Company Name: Kinamed, Inc.
• Labeler DUNS: 184896645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-04
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 599bf3c7-6394-4a19-bea6-9ba435ed093e

Device Description

1.5mm Polymer Cable with Ti Clasp

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: No
• 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
JDQ	CERCLAGE, FIXATION	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66932	Orthopaedic bone cerclage cable	An implantable braided metallic cord intended to be tightened with a crimp-like component to form a loop or ring around a fractured bone and/or fixation plate as part of an orthopaedic treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00898142001357	GS1
Package	10898142001354	GS1		3	Not in Commercial Distribution	2023-09-25
Package	20898142001351	GS1	Pack	6	Not in Commercial Distribution	2023-09-25