Pencil probe - Reusable CW Doppler pencil probe for HD307, 10 MHz - KOVEN TECHNOLOGY, INC.

Duns Number:069261402

Device Description: Reusable CW Doppler pencil probe for HD307, 10 MHz

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More Product Details

Catalog Number

PP10M5N5A

Brand Name

Pencil probe

Version/Model Number

PP10M5N5A

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

K934638

Product Code Details

Product Code

JOP

Product Code Name

Transducer, Ultrasonic

Device Record Status

Public Device Record Key

5d1c0eb4-eae4-47c7-9701-216d8f9f52a7

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

June 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVEN TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 86