Catalog Number

CIC39

Brand Name

RVG 5100

Version/Model Number

RVG 5100

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

EAP

Product Code Name

UNIT, X-RAY, INTRAORAL

Public Device Record Key

9c3ec5e0-3487-4a72-a2a3-ef0322ac78d0

Public Version Date

March 28, 2022

Public Version Number

6

DI Record Publish Date

January 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-