Duns Number:531408342
Device Description: The Tunneler is a single-use instrument consisting of a stainless steel cannula with remov The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable handle, plastic line with bullet-shaped end and barbed end, and sheath. The tunneler (65 cm) is used to make a subcutaneous tunnel between two incisions for procedures such as the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. The barbed end is intended to be connected to a 0.8 to 1.4 mm internal diameter catheter.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
990010
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"
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
K932273,K932273
Product Code
GYK
Product Code Name
Instrument, shunt system implantation
Public Device Record Key
93fd13f7-abc1-461b-a2f3-e9b9ef32ba3c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
30381780034418
Quantity per Package
5
Contains DI Package
10381780034414
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |