Duns Number:313267265
Device Description: Drill 7.0 210 AO-Connector color-coated purple non-sterile
Catalog Number
-
Brand Name
N/A
Version/Model Number
CH15007
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2021
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
0d987747-632e-4738-ae6b-0ba51b6d5d1e
Public Version Date
October 20, 2022
Public Version Number
2
DI Record Publish Date
November 01, 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 | 328 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
| U | Unclassified | 13 |