LINEAR MC 150 - R40-M-R MANUAL COLLIMATOR FOR DR - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: R40-M-R MANUAL COLLIMATOR FOR DR

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More Product Details

Catalog Number

6573786

Brand Name

LINEAR MC 150

Version/Model Number

LINEAR MC 150

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2016

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

K810598

Product Code Details

Product Code

IZX

Product Code Name

Collimator, manual, radiographic

Device Record Status

Public Device Record Key

4c7c7016-aa4a-4179-92c3-3acbfbcb7927

Public Version Date

July 06, 2018

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