Catalog Number

5154828

Brand Name

RVG 6100

Version/Model Number

RVG 6100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2018

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

EAP

Product Code Name

UNIT, X-RAY, INTRAORAL

Public Device Record Key

87d92225-ea3c-4cb8-b438-5cc9857c60dc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-