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

MR Conditional

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

-

Product Code

LGW

Product Code Name

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Public Device Record Key

9cbf5e3f-684d-4bd8-bee4-39aabc8f84a7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 29, 2015

Package DI Number

15415067024098

Quantity per Package

5

Contains DI Package

05415067024091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-