Catalog Number

g-Bolus-A

Brand Name

Bolus - Gel (film)

Version/Model Number

1

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

-

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

2ad46981-b266-4135-87dc-c9fa922dc79a

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

10628341930113

Quantity per Package

1

Contains DI Package

00628341930116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-