Duns Number:080593067
Device Description: SYRINGE 3 PARTS LUER LOCK 10 ML WITH NEEDLE 21G X 1 1/2"
Catalog Number
M803
Brand Name
MEDADV
Version/Model Number
M803
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"
Yes
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
K083686,K083686
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
bc4a147c-3ce4-4a00-a968-5235140fcdd4
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
April 11, 2018
Package DI Number
10819667020149
Quantity per Package
100
Contains DI Package
00819667020142
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |