Catalog Number

107020

Brand Name

Positilt™ Baseplate

Version/Model Number

107020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 16, 2020

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

-

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

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

be710d8e-b4e6-46de-a697-fe31f96e6fcc

Public Version Date

February 17, 2020

Public Version Number

7

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-