Duns Number:481597719
Catalog Number
1502167-001
Brand Name
0.5mm S2 Mini CARBIDE ROUND BUR
Version/Model Number
1502167
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EQJ
Product Code Name
Bur, Ear, Nose And Throat
Public Device Record Key
e2b45fc4-8c86-440c-ad1c-ee0aad576e8b
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 2020
Package DI Number
27630055504832
Quantity per Package
1
Contains DI Package
17630055504835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 69 |