Duns Number:531408342
Device Description: The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator with a su The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in the bullet-shaped tip and a stainless steel handle. The introducer is designed to be used with a sheath (inner diameter: 4 mm) to make a subcutaneous tunnel between two incisions for the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. When ordering additional sheaths, specify Catalog No. 901118 (46 cm).
Catalog Number
-
Brand Name
Integra®
Version/Model Number
901218
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
-
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
PIY
Product Code Name
Stainless steel instrument, shunt system implantation
Public Device Record Key
88a179c9-7039-48c1-8f2c-f6fb0d56ef2f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 12, 2016
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |