Duns Number:961394798
Device Description: The 12 inch x 23 inch Micro Tray, is used with the Sterilization Container System.
Catalog Number
SC134450
Brand Name
NA
Version/Model Number
SC134450
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
3c4ecffc-d382-4058-93a8-9a243f1e038a
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 |