Duns Number:044611812
Device Description: PowerPort isp M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Cath PowerPort isp M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter 8F Intermediate Kit (with Suture Plugs) (with Microintroducer)
Catalog Number
9808560
Brand Name
PowerPort isp M.R.I. Implantable Port
Version/Model Number
9808560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
f9976888-d41b-4f17-a9b8-3478de48b838
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
July 08, 2015
Package DI Number
10801741027519
Quantity per Package
5
Contains DI Package
00801741027512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |