Catalog Number

960030

Brand Name

Posicast® Thermoplastic

Version/Model Number

960030

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

-

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,K060737,K093738

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

a8c86794-ba20-4526-9ca8-827f507b1ef9

Public Version Date

August 03, 2020

Public Version Number

8

DI Record Publish Date

September 25, 2017

Package DI Number

00841439110157

Quantity per Package

10

Contains DI Package

10841439110154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-