Duns Number:066839630
Device Description: CANNULA TIP, DUAL CANNULA 5 MM X 12.5 IN
Catalog Number
-
Brand Name
NA
Version/Model Number
AMS612
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
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
d8d2f8d8-276a-4ea3-a275-8f1480985106
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
20815634020294
Quantity per Package
1
Contains DI Package
10815634020297
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIP BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |