Duns Number:790327076
Device Description: Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transp Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.
Catalog Number
7803000E74100
Brand Name
Med-Tainer Single Deposit Container (SDC)
Version/Model Number
7803000E74100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2021
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
-
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
K153274
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
57e4c7cd-d6ee-48d9-8f88-5f97899b7fda
Public Version Date
December 23, 2021
Public Version Number
4
DI Record Publish Date
September 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |