LAM Fixation Neurosurgery - LAM Set Neurosurgery bilateral with 2 x 2 MHz - Compumedics Germany GmbH

Duns Number:344791632

Device Description: LAM Set Neurosurgery bilateral with 2 x 2 MHz probes, screw topped

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More Product Details

Catalog Number

6865

Brand Name

LAM Fixation Neurosurgery

Version/Model Number

Fix_LAM_N_6865

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

b48f0301-ddad-4def-9983-0665f73f1f5e

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 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