Duns Number:083171244
Device Description: 60CM DISP PASSER PKG ASSYThe Disposable Subcutaneous Peritoneal Catheter Passer is a two-c 60CM DISP PASSER PKG ASSYThe Disposable Subcutaneous Peritoneal Catheter Passer is a two-component instrument consisting of a stainless tubular shaft with an ULTEM obturator. This product is used to provide a subcutaneous tunnel between the flushing-device site and the incision for the peritoneal catheter. The catheter consists of an open tubular shaft, concentric with a T-handled obturator which extends beyond the tubular shaft. The instrument is passed subcutaneously with the obturator assembled in the tubular shaft. Once the obturator has been removed, the catheter tubing can be passed and the tubular shaft portion of the instrument can be removed in either direction.
Catalog Number
NL8502001
Brand Name
Integra Disposable Peritoneal Catheter Passer
Version/Model Number
NL8502001
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"
-
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
K895868,K895868
Product Code
GYK
Product Code Name
Instrument, shunt system implantation
Public Device Record Key
50311759-f8ce-4599-bd47-f8eada0441a2
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2015
Package DI Number
30381780072366
Quantity per Package
6
Contains DI Package
10381780072362
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |