Duns Number:002348191
Device Description: SharpsAway II(TM) Locking Disposal Cup
Catalog Number
SA-00011-BNS
Brand Name
ARROW
Version/Model Number
IPN035923
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
K041153,K041153,K041153
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
3fb1075b-846e-431e-9d8a-bbc59bf4a8e2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 23, 2016
Package DI Number
30801902131110
Quantity per Package
1
Contains DI Package
10801902131116
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |