Catalog Number

1194

Brand Name

Cinch™

Version/Model Number

1194

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081208,K081208

Product Code

GZB

Product Code Name

STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Public Device Record Key

98ee35ef-9bfc-4c43-9c49-805d79e4c223

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 15, 2015

Package DI Number

15414734400685

Quantity per Package

5

Contains DI Package

05414734400688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-