Duns Number:486711679
Device Description: SOLID BASE FOR EXTENDED-FIVE LEVEL STERILIZATION CONTAINER
Catalog Number
62019035
Brand Name
NA
Version/Model Number
62.019.035
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
-
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
K130720,K181933
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
7a12d439-bdbd-4afd-88ba-918e9c6ce816
Public Version Date
May 30, 2022
Public Version Number
7
DI Record Publish Date
June 30, 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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |