Catalog Number

OP0908-901

Brand Name

V. Mueller

Version/Model Number

OP0908-901

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

-

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

FHQ

Product Code Name

HOLDER, NEEDLE, GASTROENTEROLOGIC

Public Device Record Key

0d4db6c5-22e4-4100-b6f3-2c6bf8a64a75

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

September 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-