Catalog Number

KTT100

Brand Name

Infinity

Version/Model Number

KTT100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2020

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

bf6060b8-355c-474b-ac9b-4312b1b9ca2f

Public Version Date

November 27, 2020

Public Version Number

3

DI Record Publish Date

October 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-