Duns Number:612611459
Device Description: Cranial Perforator
Catalog Number
210-221 CDM
Brand Name
Disposable Cranial Perforator
Version/Model Number
210-221 14/11 mm
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K833266
Product Code
HBF
Product Code Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Public Device Record Key
2b64c87c-8247-4bbe-b9e8-784712fcbfd8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 01, 2017
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |