Duns Number:080935429
Device Description: Sharps Container,Rotor/Hinged Lid, Transparent Yellow
Catalog Number
8525Y
Brand Name
SharpSafety
Version/Model Number
8525Y
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)
-
Over the Counter (OTC)
Yes
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
942eb867-6237-4979-9590-7049a91bae6c
Public Version Date
February 15, 2019
Public Version Number
7
DI Record Publish Date
January 07, 2017
Package DI Number
20884521020273
Quantity per Package
10
Contains DI Package
10884521020276
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 |