Catalog Number

222669

Brand Name

LCP

Version/Model Number

222.669

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 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

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

K000066

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

b24a7a40-c642-4ad7-a7bc-3a6151d932c1

Public Version Date

July 27, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-