LAM Fixation Standard - LAM Sets Standard bilateral with 2 x 1 MHz - Compumedics Germany GmbH

Duns Number:344791632

Device Description: LAM Sets Standard bilateral with 2 x 1 MHz probes, click&stay

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More Product Details

Catalog Number

7514

Brand Name

LAM Fixation Standard

Version/Model Number

FIx_LAM_S_7514

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

K051085

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

cdca0a91-3278-4b70-8ba1-88882115bc27

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPUMEDICS GERMANY GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 134