Duns Number:057188807
Device Description: The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
Catalog Number
-
Brand Name
DET 2006 Detachable Pachymeter Probe
Version/Model Number
DET 2006
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
K033385
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
61012a91-6c37-4989-8fb6-74afc9d28c99
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 |