READYMATIC Fixer and Replenisher - READYMATIC Fixer and Repl - 4x1GL - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: READYMATIC Fixer and Repl - 4x1GL

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More Product Details

Catalog Number

8712879

Brand Name

READYMATIC Fixer and Replenisher

Version/Model Number

READYMATIC Fixer and Replenisher

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 04, 2020

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

b38edf0b-4470-4abb-b6a8-b6488123297c

Public Version Date

June 08, 2020

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