Duns Number:080935429
Device Description: Tortuous Path Sharps Container,Clear
Catalog Number
31143897
Brand Name
Sharps-A-Gator
Version/Model Number
31143897
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
049610b8-0bab-47ef-a10d-fc963f4bd6b5
Public Version Date
June 17, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521022956
Quantity per Package
30
Contains DI Package
10884521022959
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 |