Catalog Number

GALH-102a

Brand Name

Healgen

Version/Model Number

GALH-102a

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)

Yes

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

cbc949b2-8e10-4d28-a1cb-84636b72c7d0

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 12, 2019

Package DI Number

20816490023559

Quantity per Package

120

Contains DI Package

10816490023552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case