Duns Number:989925396
Device Description: CUSA Clarity 36kHz Curved Extended MicroTip Plus
Catalog Number
C7415S
Brand Name
CUSA® Clarity
Version/Model Number
C7415S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
-
Product Code
LBK
Product Code Name
Device, neurosurgical fragmentation and aspiration
Public Device Record Key
95c15659-1ec1-4017-8573-3effc4525691
Public Version Date
October 04, 2022
Public Version Number
7
DI Record Publish Date
November 23, 2016
Package DI Number
30381780126373
Quantity per Package
5
Contains DI Package
10381780126379
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |