Duns Number:073724333
Device Description: The Sterilization Tray is comprised of a lid and a base component. The sterilization tray The Sterilization Tray is comprised of a lid and a base component. The sterilization tray base has been preconfigured with receiving slots for the Delivery Device and Quick Release Device accessory components.
Catalog Number
MI-XC-T-001
Brand Name
MI DeTACH - Aortic Cross Clamp - Delivery System Sterilization Tray
Version/Model Number
1.0
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
-
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
d4abe00d-a2a5-4760-9cee-3a422f88886d
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 17, 2021
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 | 1 |