Rapid Access Twin Pack - RAPID ACCESS TWIN PACK, 6 X 500 ML - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: RAPID ACCESS TWIN PACK, 6 X 500 ML

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More Product Details

Catalog Number

8606899

Brand Name

Rapid Access Twin Pack

Version/Model Number

Rapid Access Twin Pack

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)

-

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

0d071792-9284-428f-9e95-1ea6efa8d3fe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2017

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