Catalog Number

P4S-3,15-3

Brand Name

Prosthetic Accessories

Version/Model Number

P4S-3,15-3

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

K182455,K182455

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

e29adfb8-d085-43f3-be03-3b71e6feb012

Public Version Date

October 07, 2019

Public Version Number

1

DI Record Publish Date

September 29, 2019

Package DI Number

17290111273411

Quantity per Package

10

Contains DI Package

07290111273414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag