Duns Number:785616934
Device Description: 3.5 mm dia. x 13 cm Length Spherical Bur
Catalog Number
-
Brand Name
Reprocessed 3.5mm Spherical Bur
Version/Model Number
H9110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
dd59584a-bc7f-4175-8b71-f50b5e4cf664
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
March 30, 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 | 616 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 118 |