Catalog Number

I-K1852TS41

Brand Name

INSTRUMENT

Version/Model Number

I-K1852TS41

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HTZ

Product Code Name

INSTRUMENT, CUTTING, ORTHOPEDIC

Public Device Record Key

fe886780-c77e-4665-9299-0786aec2f981

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-