Duns Number:047644935
Device Description: CystoAssist Accessory Sterilization Tray - 3.15 x 3.15 x 1.6" (80 x 80 x 40 cm )
Catalog Number
-
Brand Name
Trays
Version/Model Number
87006-AT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
2f8047be-cb1c-4778-b03d-3c8c9c3d64be
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 2022
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 | 882 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |