Catalog Number

110017406

Brand Name

Ratchet Handle

Version/Model Number

110017406

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

K140891,K142658,K143188,K190035

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

dcd5df1d-dbc4-4469-8ed3-8483dd7ca03f

Public Version Date

June 04, 2021

Public Version Number

2

DI Record Publish Date

March 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-