Catalog Number

P5-3.75,4

Brand Name

Prosthetic Accessories

Version/Model Number

P5-3.75,4

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

8f9e7a49-95b1-49cf-9b28-1f2ac1ec5b83

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Package DI Number

27290107272999

Quantity per Package

100

Contains DI Package

17290107272992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag