Duns Number:080935429
Device Description: Sharps Container,Gasketed Slide Lid, Red
Catalog Number
8997S
Brand Name
SharpSafety
Version/Model Number
8997S
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
c5275a00-d85c-413a-b906-765c7cc1be65
Public Version Date
February 15, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521022529
Quantity per Package
10
Contains DI Package
30884521022526
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 |