Duns Number:078846878
Device Description: The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
Catalog Number
41.157.101
Brand Name
Single Pass Tunneling Guidewire - Small
Version/Model Number
41.157.101
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"
-
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
GYK
Product Code Name
Instrument, Shunt System Implantation
Public Device Record Key
cd14908d-ad17-49b2-976c-4b6e5733d394
Public Version Date
August 22, 2022
Public Version Number
4
DI Record Publish Date
December 14, 2018
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |