Duns Number:061310132
Device Description: MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MGPLB
Catalog Number
-
Brand Name
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus
Version/Model Number
D9-7006MGPLB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2020
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
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
FIE
Product Code Name
Needle, Fistula
Public Device Record Key
4fdf5b63-d340-443d-9819-99bc1b7fdd21
Public Version Date
July 13, 2020
Public Version Number
3
DI Record Publish Date
October 24, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 167 |