Catalog Number

GNRL05

Brand Name

N/A

Version/Model Number

GNRL05

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

a7d37166-4adb-4218-8c56-331aafdc740c

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

June 06, 2017

Package DI Number

20705036015922

Quantity per Package

6

Contains DI Package

10705036015925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX