Duns Number:751993028
Device Description: The saleable unit (device count) is 1, there are 5 surgibit drills in the saleable unit
Catalog Number
-
Brand Name
1.1 x 100 mm Surgibit Drill
Version/Model Number
192-11-0011
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
HTW
Product Code Name
Bit, Drill
Public Device Record Key
bc6401fc-28b8-4a54-a157-004ba4425319
Public Version Date
September 10, 2020
Public Version Number
2
DI Record Publish Date
November 05, 2019
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 | 1701 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3746 |