Duns Number:117070072
Device Description: Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8" (3.5cm)
Catalog Number
AP040135
Brand Name
INTERA
Version/Model Number
AP-04013-5
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
K211121,P890055,K211121,P890055
Product Code
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
f209d06b-e102-4bf4-967f-70c77e3f3c9f
Public Version Date
November 09, 2021
Public Version Number
3
DI Record Publish Date
October 06, 2021
Package DI Number
10850014110045
Quantity per Package
5
Contains DI Package
00850014110048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 3 |