Catalog Number

60023

Brand Name

VeraForm

Version/Model Number

60023

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

Yes

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

K190155,K190155,K190155

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

6d633c86-a3fa-4e2b-9903-c1692c62312d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

June 23, 2021

Package DI Number

00850016008046

Quantity per Package

5

Contains DI Package

00850016008039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton