Duns Number:315304071
Device Description: DRILL GUIDE FOR HOLLOW DRILL BIT SZ 9 for tibial aiming device, for use with base section DRILL GUIDE FOR HOLLOW DRILL BIT SZ 9 for tibial aiming device, for use with base section 8874111 and HOLLOW DRILL 8869851 SZ 9, modular, reusable
Catalog Number
8874.152
Brand Name
NA
Version/Model Number
8874152
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)
-
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
f386cfcf-6b8a-4ec3-9b2a-5a4a1e56f745
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |