RP X-OMAT Developer and Replenisher - RP X-OMAT DEVELOPER AND REPL PT A 200GL - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: RP X-OMAT DEVELOPER AND REPL PT A 200GL

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More Product Details

Catalog Number

1318989

Brand Name

RP X-OMAT Developer and Replenisher

Version/Model Number

RP X-OMAT Developer and Replenisher

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2021

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)

-

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

IWZ

Product Code Name

Film, radiographic

Device Record Status

Public Device Record Key

a710bb4a-edd7-4111-85e7-4caed598b345

Public Version Date

June 25, 2021

Public Version Number

3

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