Adapter cable 16 MHz probe, 1mm - Adapter cable 16 MHz probe, 1.0 mm diameter for - Compumedics Germany GmbH

Duns Number:344791632

Device Description: Adapter cable 16 MHz probe, 1.0 mm diameter for patient Isolation

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More Product Details

Catalog Number

6000

Brand Name

Adapter cable 16 MHz probe, 1mm

Version/Model Number

AdCab_16 MHz_1

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

5c00c961-4830-46ca-8c64-d8ed65998397

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

November 04, 2016

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