Catalog Number

345SVVO

Brand Name

Ruhof Scope Valet Guardian

Version/Model Number

345SVVO

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

2a38dc07-6836-4ac8-a9bf-cbc1bb0db3cf

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

10810929019598

Quantity per Package

25

Contains DI Package

00810929019591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box