Catalog Number

-

Brand Name

2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim, Left, 4 holes

Version/Model Number

Ti-544.004L

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

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

K211324

Product Code

HRC

Product Code Name

Sterilizer, Soft-Lens, Thermal, Battery-Powered

Public Device Record Key

cb084e5c-4a73-44a5-99ba-f0886e1dcf20

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-