Duns Number:262951353
Device Description: Disposable catheter passer with sheath, 30 cm length
Catalog Number
-
Brand Name
Phoenix Neuro
Version/Model Number
SP05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K853370
Product Code
GYK
Product Code Name
Instrument, shunt system implantation
Public Device Record Key
e852e3e4-0390-44d4-8a4f-8b1602eab79f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 16, 2015
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 223 |