Catalog Number

GL3608-001

Brand Name

V. Mueller

Version/Model Number

GL3608-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2021

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

-

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

HGC

Product Code Name

CLAMP, UTERINE

Public Device Record Key

d5ba11a6-ddc1-4efb-bf2b-4e3327fb50f1

Public Version Date

March 07, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-