SuperCable® Iso-Elastic™ Cerclage System 35-100-1040

GUDID 00818720011349

1.5mm Polymer Cable with Ti Clasp

Kinamed, Inc.

Orthopaedic bone wire

• Primary Device ID: 00818720011349
• NIH Device Record Key: bab442fa-3761-46f8-aa67-ee9978a3d7e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperCable® Iso-Elastic™ Cerclage System
• Version Model Number: 35-100-1040
• Catalog Number: 35-100-1040
• Company DUNS: 184896645
• Company Name: Kinamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818720011349 [Primary]
GS1	30818720011340 [Package]; Package: Pack [6 Units]; In Commercial Distribution
GS1	40818720011347 [Package]; Package: Pack [3 Units]; In Commercial Distribution

FDA Product Code

• JDQ: Cerclage, fixation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-23
• Device Publish Date: 2018-11-05

On-Brand Devices [SuperCable® Iso-Elastic™ Cerclage System]

• 00818720011660: Cable Passer Instrument, 1.5mm
• 00818720011349: 1.5mm Polymer Cable with Ti Clasp
• 00818720013299: TalonPasser™, Large, 60mm
• 00818720013336: TalonPasser™, Medium, 40mm
• 00818720013329: TalonPasser™, Small, 40mm
• 00818720013312: TalonPasser™, Small, 60mm
• 00818720013305: TalonPasser™, Medium, 60mm
• 00818720012797: Sternotomy Closure Kit (contains 2 EA. 1.5mm Polymer Cable and 1 EA. Curved Mini Passer)
• 00818720012780: Sternotomy Closure Kit (contains 4 EA. 1.5mm Polymer Cable and 1 EA. Curved Mini Passer)
• 00898142001432: Wedge Removal Tool
• 00898142001425: Autoclave Case
• 00898142001418: Cable Passer, 60mm
• 00898142001401: Cable Passer, 40mm
• 00898142001395: Cable Tensioning Instrument
• 00818720012995: Cerclage Instruments Case Base
• 00818720012988: Cerclage Instruments Case Lid
• 00818720012933: Tensioner Lever Extender
• 00818720012926: Cable Passer, 60mm, Angled
• 00818720012919: Cable Passer, 40mm, Angled
• 00818720012902: Tensioner Crank Handle
• 00818720012858: Cable Passer, 60mm
• 00818720012841: Cable Passer, 40mm
• 00818720012490: MultiMax Tensioning Instrument
• 00818720012384: Cable Passer, 50mm, Angled
• 00818720012377: Cable Passer, 50mm
• 00818720011875: Cable Passer, 60mm, Extended
• 00818720011868: Cable Passer, 40mm, Extended
• 00818720011424: Cable Tensioning Instrument, 60° Angled
• 00818720011417: Forceps Wedge Remover, 1mm
• 00818720011394: Cable Passer, 60mm, Angled
• 00818720011387: Cable Passer, 40mm, Angled
• 00818720011370: Cable Passer, 30mm
• 00818720011363: Straight Tensioner, ACME
• 00818720011332: Curved Mini Passer (For use with 1.5mm SuperCable Implant)
• 00818720012735: 38-800-3500
• 00898142001968: Cable Passer, Angled-Sharp, 50mm
• 00898142001715: Cable Passer, Angled-Sharp, 60mm
• 00818720013367: Cable Passer, Angled-Sharp, 40mm
• 00818720013350: Cable Passer, Angled, 60mm, Opened to 75mm
• 00898142001975: 1.0mm Polymer Cable with Ti Clasp
• 00898142001357: 1.5mm Polymer Cable with Ti Clasp