Duns Number:088013219
Device Description: TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2004M TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2004MGP
Catalog Number
-
Brand Name
masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS
Version/Model Number
D9-2004MGP
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"
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
13cd6a0f-1d86-4ff1-b733-fe7add219a17
Public Version Date
July 16, 2020
Public Version Number
1
DI Record Publish Date
July 08, 2020
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. | 211 |