Duns Number:080935429
Device Description: 12 mL Syringe with Standard Hypodermic Needle
Catalog Number
1181220112
Brand Name
Monoject
Version/Model Number
1181220112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2017
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
ff69693c-6209-484d-91b4-1f9ef8111888
Public Version Date
February 15, 2019
Public Version Number
5
DI Record Publish Date
October 13, 2016
Package DI Number
30884521010400
Quantity per Package
480
Contains DI Package
10884521010406
Package Discontinue Date
April 21, 2017
Package Status
Not 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 |