Catalog Number

BMCG-1

Brand Name

Cook

Version/Model Number

G21992

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2016

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

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

8229d4e7-99b8-42ab-a90d-d9ea87def7d6

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-