CT Simulation Laser QA Device - CT Simulation Laser QA Device - MEDTEC, INC.

Duns Number:103977526

Device Description: CT Simulation Laser QA Device

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More Product Details

Catalog Number

MTTG66

Brand Name

CT Simulation Laser QA Device

Version/Model Number

MTTG66

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

LHO

Product Code Name

Instrument, quality-assurance, radiologic

Device Record Status

Public Device Record Key

d37e9ac1-0587-45e7-8f6c-fe40677106d3

Public Version Date

March 27, 2020

Public Version Number

5

DI Record Publish Date

August 02, 2017

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