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

GUDID 00818720011349

1.5mm Polymer Cable with Ti Clasp

Kinamed, Inc.

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable Orthopaedic bone cerclage cable

• 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