Duns Number:081277700
Device Description: Craniotomy Kit: Disposable Perforator Cranio-blade Wire Pass Drill
Catalog Number
26-1230
Brand Name
CODMAN®
Version/Model Number
261230
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073336
Product Code
HBF
Product Code Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
Public Device Record Key
b04979ec-7a53-4cdc-8d02-f338796239ef
Public Version Date
October 03, 2022
Public Version Number
4
DI Record Publish Date
April 01, 2020
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |