Duns Number:961394798
Device Description: The 11 inch x 19 inch Solid Lid Container System is used with the Sterilization Container
Catalog Number
SC133050
Brand Name
NA
Version/Model Number
SC133050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 2022
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
K850289
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
d1571195-65e7-44ad-a7fa-143aa2004792
Public Version Date
October 31, 2022
Public Version Number
9
DI Record Publish Date
September 14, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |