Duns Number:079116867
Device Description: 1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.
Catalog Number
A-CRN
Brand Name
NA
Version/Model Number
A-CRN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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
Yes
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
K011444
Product Code
ERL
Product Code Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Public Device Record Key
76c2bec7-c27c-4c8c-98fc-05bf79601717
Public Version Date
May 20, 2022
Public Version Number
5
DI Record Publish Date
September 09, 2016
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 | 294 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 910 |