Duns Number:783518983
Device Description: ZevRx STERILE INSULIN SYRINGE 5/16” 1CC 30G100 SYRINGES / BOXINDIVIDUALLY WRAPPED
Catalog Number
-
Brand Name
ZevRx STERILE INSULIN SYRINGE 5/16” 1CC 30G
Version/Model Number
1
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
4ee60d87-aac7-4f44-8c1f-6293e0661eac
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
Package DI Number
10850632007741
Quantity per Package
20
Contains DI Package
00850632007744
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |
U | Unclassified | 11 |