Duns Number:202659140
Device Description: The Reliance Endoscope Transport cart is designed to safely and easily transport endoscope The Reliance Endoscope Transport cart is designed to safely and easily transport endoscopes to a procedure room or to reprocessing.
Catalog Number
RETCART01
Brand Name
Reliance
Version/Model Number
RETCART01
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
-
Product Code
FFY
Product Code Name
Adaptor, bulbs, miscellaneous, for endoscope
Public Device Record Key
70906f31-388a-4aa9-a9eb-9b774c3d7902
Public Version Date
October 04, 2022
Public Version Number
2
DI Record Publish Date
March 23, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |