Duns Number:783518983
Device Description: ZevRx STERILE PEN NEEDLES 4mm 32GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXSINGLE USE ZevRx STERILE PEN NEEDLES 4mm 32GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXSINGLE USE DISPOSABLE NEEDLEUNIVERSAL FIT FOR MOST PEN SYSTEMS
Catalog Number
-
Brand Name
ZevRx STERILE PEN NEEDLES 4mm 32G
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
934c029f-ac28-4b0f-b8e0-c962658ee2f8
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
Package DI Number
10850632007802
Quantity per Package
50
Contains DI Package
00850632007805
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 |