Catalog Number

-

Brand Name

ET Control Device V

Version/Model Number

H-V100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2022

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

-

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

FFR

Product Code Name

DEVICE, LOCKING, FOR INTESTINAL CLAMP

Public Device Record Key

2b79a3a2-3f95-4114-b98e-038b9283d998

Public Version Date

August 22, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-