Phantom Mount - For use with Philips Brilliance Universal - MEDTEC, INC.

Duns Number:103977526

Device Description: For use with Philips Brilliance Universal Couchtop™

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More Product Details

Catalog Number

MTIL640040

Brand Name

Phantom Mount

Version/Model Number

MTIL640040

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

K973842

Product Code Details

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Device Record Status

Public Device Record Key

aef6f324-f0d7-4ef4-841c-1a858f24deab

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

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