Duns Number:011441508
Device Description: Mini Multi-Purpose Driver Long 1.65 mm
Catalog Number
-
Brand Name
Park Dental Research Corp.
Version/Model Number
DRVRT-1.65L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
42723342-7178-4de6-9cef-dcf6d71a7a00
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 46 |
2 | A medical device with a moderate to high risk that requires special controls. | 62 |