Duns Number:020417380
Device Description: Sterile Single Use Burs - ISO Code 847-016C
Catalog Number
1023945
Brand Name
Safco D1amond
Version/Model Number
1023945
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
Yes
Prescription Use (Rx)
-
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
93ced7a6-837e-44c3-bdca-7ca0dc3e7909
Public Version Date
August 18, 2021
Public Version Number
2
DI Record Publish Date
June 24, 2021
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 | 600 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |