Duns Number:009900424
Device Description: Cylinder Flat-End Long Medium Grit FG Diamond ISO# 110-013 (Pkg. of 10 pcs.)
Catalog Number
SD110-013
Brand Name
Parkell®
Version/Model Number
SD110-013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2020
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
Yes
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
DZP
Product Code Name
Instrument, Diamond, Dental
Public Device Record Key
97498c9a-f4e5-4cf2-b15c-128468535c24
Public Version Date
November 24, 2020
Public Version Number
3
DI Record Publish Date
March 29, 2019
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |