Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8506SA
Brand Name
SharpSafety
Version/Model Number
8506SA
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
MMK
Product Code Name
Container, sharps
Public Device Record Key
0dec8f9c-0ecf-4823-bf5c-67251952d0c1
Public Version Date
March 02, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884521023250
Quantity per Package
20
Contains DI Package
10884521023253
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 |