Duns Number:061310132
Device Description: MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARDTotal Case Qty 250 (I MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARDTotal Case Qty 250 (Includes 120 Twin Pouches + 10 Single Pouches)
Catalog Number
-
Brand Name
Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard
Version/Model Number
D9-2016MG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 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
c6eb58a4-8cde-4f74-a5db-46f573da44b7
Public Version Date
February 23, 2021
Public Version Number
3
DI Record Publish Date
September 16, 2016
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 |