Catalog Number

PRO430

Brand Name

ProForm™ Pediatric Thermoplastic

Version/Model Number

PRO430

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

K180021,K180021

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

6acf763a-8f6f-4df6-bbdb-445ca3400f60

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Package DI Number

10841439113964

Quantity per Package

5

Contains DI Package

00841439113967

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-