Duns Number:012430880
Device Description: Carbide Bur HP 8
Catalog Number
5700189
Brand Name
Henry Schein
Version/Model Number
5700189
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
-
Product Code
EJL
Product Code Name
BUR, DENTAL
Public Device Record Key
952fb335-2a26-4c7f-b4cb-2be5322c8dab
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
November 12, 2019
Package DI Number
10304040076306
Quantity per Package
10
Contains DI Package
00304040076309
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |