Duns Number:080935429
Device Description: Insulin Syringe with Extra Fine Needle
Catalog Number
8881601002
Brand Name
Monoject
Version/Model Number
8881601002
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
6d4874e1-96f5-4cc5-a2c1-21e95526a808
Public Version Date
February 15, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521151847
Quantity per Package
300
Contains DI Package
00884521169213
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |