SCAN CEPH - SCAN CEPH UPGRADE FOR CS 8100 3D - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: SCAN CEPH UPGRADE FOR CS 8100 3D

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More Product Details

Catalog Number

5500434

Brand Name

SCAN CEPH

Version/Model Number

SCAN CEPH

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

MUH

Product Code Name

System,x-ray,extraoral source,digital

Device Record Status

Public Device Record Key

89268c72-136c-4557-8279-bf80b8ae1afa

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 22, 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