Catalog Number

101019

Brand Name

Posifix® -1 Baseplate

Version/Model Number

101019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

K060737,K093738

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

202c6dc7-e2b4-4ba8-9169-54eb026afe6d

Public Version Date

December 22, 2020

Public Version Number

6

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-