Catalog Number

295507

Brand Name

Biotrol

Version/Model Number

295507

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRJ

Product Code Name

Disinfectant, medical devices

Public Device Record Key

5e76d374-b5c7-4864-936d-3d53e4607bcc

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

20302732955073

Quantity per Package

6

Contains DI Package

00302732955079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case