Duns Number:481597719
Catalog Number
1100431-001
Brand Name
Bur PM2-70 50K carbide conical Ø7.0mm sterile
Version/Model Number
1100431
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
c2accf6a-2ab7-48dc-a193-2e7e2aefc388
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 2020
Package DI Number
27630055503873
Quantity per Package
1
Contains DI Package
17630055503876
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 |