DGH 2006 Corded Pachymeter Probe - The DGH2006 is an angled corded probe containing - DGH TECHNOLOGY INC.

Duns Number:057188807

Device Description: The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is u The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.

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More Product Details

Catalog Number

-

Brand Name

DGH 2006 Corded Pachymeter Probe

Version/Model Number

DGH 2006

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

K920906

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

7df38dc8-d1e1-47f0-99a1-f509be9fc450

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DGH TECHNOLOGY INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21