Duns Number:057188807
Device Description: The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is used with The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices.
Catalog Number
-
Brand Name
DGH 6006 Corded A-Scan Probe
Version/Model Number
DGH 6006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K093371
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
8ae6e6dd-826e-41ca-81cf-e85783208b94
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |