Duns Number:531408342
Device Description: The 46 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer The 46 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of appropriate length (46 cm) during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. It features a tapered tip to facilitate subcutaneous insertion and passage.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
901118
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
K771529,K771529
Product Code
GYK
Product Code Name
Instrument, shunt system implantation
Public Device Record Key
116026dd-75e6-4cd8-9b44-b001596230c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
30381780033176
Quantity per Package
5
Contains DI Package
10381780033172
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 |