Duns Number:057188807
Device Description: The pachymeter calbox is an accessory that connects to a pachymeter and creates a series o The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
Catalog Number
-
Brand Name
Pachmate Calbox
Version/Model Number
DGH 55 Calbox
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
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
1dfc1681-70a4-4cb9-b912-d7104ecdb590
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 |