Duns Number:118087931
Device Description: TRAY, STERILIZATION/STORAGEDM: 20.75" 9.75" X 3.5"
Catalog Number
KSE09017
Brand Name
KARL STORZ
Version/Model Number
KSE09017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012105
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
d89cbcf9-b2fb-4104-816b-b89d6d55863b
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
December 12, 2019
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. | 133 |