Catalog Number

-

Brand Name

Toe Hemi Edge PC LG

Version/Model Number

19819

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

-

Product Code

KWD

Product Code Name

Prosthesis, Toe, Hemi-, Phalangeal

Public Device Record Key

d9220582-f601-4462-a133-b496dc90b21f

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-