RVG 6100 - CAPTEUR RVG 6100 T1 FLASH - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: CAPTEUR RVG 6100 T1 FLASH

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More Product Details

Catalog Number

CIA77

Brand Name

RVG 6100

Version/Model Number

RVG 6100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EAP

Product Code Name

UNIT, X-RAY, INTRAORAL

Device Record Status

Public Device Record Key

259e54c5-c340-4804-9d03-1266ece43d4d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688