Catalog Number

-

Brand Name

TSI

Version/Model Number

TK-1205

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161318

Product Code

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Public Device Record Key

92036284-2bea-4e71-859b-d076db5cd01f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-