Duns Number:437222573
Device Description: STORASCOPE Cart with 10 standard trays and lids has been designed to provide a safe and hy STORASCOPE Cart with 10 standard trays and lids has been designed to provide a safe and hygienic method of transport and short-term storage of flexible endoscopes and other sensitive medical equipment.
Catalog Number
103548
Brand Name
STORASCOPE
Version/Model Number
Endoscope Storage and Transportation Carts
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)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FFY
Product Code Name
Adaptor, bulbs, miscellaneous, for endoscope
Public Device Record Key
2370218e-cb86-4230-aecf-00c3472aa979
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 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 | 16 |