Catalog Number

35-100-1010

Brand Name

SuperCable® Iso-Elastic™ Cerclage System

Version/Model Number

35-100-1010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JDQ

Product Code Name

CERCLAGE, FIXATION

Public Device Record Key

599bf3c7-6394-4a19-bea6-9ba435ed093e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 04, 2015

Package DI Number

10898142001354

Quantity per Package

3

Contains DI Package

00898142001357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-