Docking Station - For use with Siemens Vario 2 CT - MEDTEC, INC.

Duns Number:103977526

Device Description: For use with Siemens Vario 2 CT

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More Product Details

Catalog Number

MTIL600812

Brand Name

Docking Station

Version/Model Number

MTIL600812

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

K180021

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

57db9b75-192e-4bb8-83f8-01c82dcad98f

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1027