Duns Number:832426782
Device Description: IV SYRINGE, 10cc
Catalog Number
ZZ-0070
Brand Name
IV Syringe
Version/Model Number
ZZ-0070
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2018
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
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
28de72f4-4c3c-4d2c-b6a4-6f650b48b4cc
Public Version Date
January 27, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2018
Package DI Number
10842209107343
Quantity per Package
100
Contains DI Package
00842209107346
Package Discontinue Date
September 22, 2018
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |