Meniett™ Power Supply - Lina Medical ApS

Duns Number:305088619

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More Product Details

Catalog Number

MT-POW

Brand Name

Meniett™ Power Supply

Version/Model Number

MT-POW

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

ETY

Product Code Name

Tester, Auditory Impedance

Device Record Status

Public Device Record Key

44dc1d9d-0ca2-4391-806c-8729cefee6de

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

November 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LINA MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 44