Catalog Number

9000803

Brand Name

Preat Implant Prosthetics

Version/Model Number

9000803

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

04bc5e95-63a4-40fd-a34c-978f7695e125

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

October 07, 2022

Package DI Number

00842092156780

Quantity per Package

10

Contains DI Package

00842092175781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-