Catalog Number

P64-bT

Brand Name

Prosthetic Accessories

Version/Model Number

P64-bT

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

-

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

733ce9cd-cc73-42a3-b9b0-414ca865f5a4

Public Version Date

October 07, 2019

Public Version Number

1

DI Record Publish Date

September 29, 2019

Package DI Number

17290111274029

Quantity per Package

10

Contains DI Package

07290111274022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag