Catalog Number

PRO340

Brand Name

Registration Film

Version/Model Number

PRO340

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

K180021,K180021

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

65b5dafd-d291-483c-b673-1415826a0e1e

Public Version Date

August 11, 2022

Public Version Number

3

DI Record Publish Date

October 10, 2019

Package DI Number

10841439113056

Quantity per Package

5

Contains DI Package

00841439113059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-