Duns Number:315427286
Device Description: Grinding points, brown, soft, medium grain size, Form: wheel, inverted conical and conical Grinding points, brown, soft, medium grain size, Form: wheel, inverted conical and conical, proximal concave
Catalog Number
-
Brand Name
N.A.
Version/Model Number
132-204-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2021
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
EHJ
Product Code Name
DISK, ABRASIVE
Public Device Record Key
98e2a5a7-6903-4711-ae52-fb1f744df867
Public Version Date
September 07, 2021
Public Version Number
2
DI Record Publish Date
August 28, 2020
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |