Catalog Number

P4-3.75,17-1

Brand Name

Prosthetic Accessories

Version/Model Number

P14-3.75,17-1

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

K132125,K132125,K132125

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

b476b8cd-4a09-4d83-9388-4a03b6c9060c

Public Version Date

January 14, 2020

Public Version Number

2

DI Record Publish Date

June 11, 2019

Package DI Number

17290107279809

Quantity per Package

10

Contains DI Package

07290107279802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

beg