Duns Number:961027315
Device Description: 2.7mm Drill Bit QC/125mm Material: Stainless Steel
Catalog Number
DB27-003
Brand Name
CARDINAL HEALTH
Version/Model Number
DB27-003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 2018
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
60f3bb9d-a70c-46a3-aea6-1a91cc9e9713
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
June 05, 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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |