Catalog Number

-

Brand Name

GaleMed

Version/Model Number

71050

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"

Yes

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

BXO

Product Code Name

Transducer, Gas Pressure

Public Device Record Key

919c164e-1024-4c68-bd6d-82c1074f0351

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2015

Package DI Number

44710810084124

Quantity per Package

2

Contains DI Package

04710810084126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton