Rectangular Extension - For use with Universal Couchtop™ Long Extension - MEDTEC, INC.

Duns Number:103977526

Device Description: For use with Universal Couchtop™ Long Extension

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More Product Details

Catalog Number

MTIL6669

Brand Name

Rectangular Extension

Version/Model Number

MTIL6669

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,K973842

Product Code Details

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Device Record Status

Public Device Record Key

e4be768e-9e8f-4b23-bc98-e2f853d408fd

Public Version Date

April 10, 2020

Public Version Number

6

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