Duns Number:080935429
Device Description: 12 mL Syringe with Hypodermic Safety Needle
Catalog Number
8881822015
Brand Name
Magellan
Version/Model Number
8881822015
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)
Yes
Over the Counter (OTC)
-
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
8eb90496-f892-45b5-945e-a971118f4a4f
Public Version Date
September 09, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
30884521005512
Quantity per Package
200
Contains DI Package
10884521005518
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 |