Duns Number:486711679
Device Description: 1.1MM DRILL BIT 4MM STOP/52MM HXC
Catalog Number
316624
Brand Name
NA
Version/Model Number
316.624
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
K043310,K043310
Product Code
HBE
Product Code Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
Public Device Record Key
d6f4be21-de4a-4038-8f5d-b5d805415864
Public Version Date
April 25, 2022
Public Version Number
3
DI Record Publish Date
September 21, 2018
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 | 8630 |
2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
U | Unclassified | 2 |