AccessGUDID - DEVICE: SuperCable® Iso-Elastic™ Cerclage System (00818720011349)

GUDID

Device Identifier (DI) Information

Brand Name: SuperCable® Iso-Elastic™ Cerclage System
Version or Model: 35-100-1040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35-100-1040
Company Name: Kinamed, Inc.

Primary DI Number: 00818720011349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184896645 *Terms of Use

Device Description: 1.5mm Polymer Cable with Ti Clasp

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	Cerclage, fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bab442fa-3761-46f8-aa67-ee9978a3d7e5
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: November 05, 2018