Duns Number:079105071
Device Description: 3MM J TIP, AMPLATZ MOVABLE CORE, PTFE COATED
Catalog Number
-
Brand Name
AngioDynamics
Version/Model Number
05500102
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 23, 2021
Issuing Agency
In HIBCC
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
-
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
001c165b-fb88-4e60-9c79-d703056a9ad6
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
H787055001022
Quantity per Package
10
Contains DI Package
H787055001021
Package Discontinue Date
September 23, 2021
Package Status
Not 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |