Duns Number:202659140
Device Description: The 5000 Series Reliance Endoscope Drying and Storage Cabinet, 20 Scopes, Add-on is design The 5000 Series Reliance Endoscope Drying and Storage Cabinet, 20 Scopes, Add-on is designed to ensure a clean storage location for disinfected endoscopes and to protect the endoscopes from damage while in storage.
Catalog Number
REC5202DSA
Brand Name
Reliance
Version/Model Number
5000 Series
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
JRJ
Product Code Name
UNIT, DRYING
Public Device Record Key
c178e453-b883-4148-89aa-09a5ce89a909
Public Version Date
February 15, 2021
Public Version Number
1
DI Record Publish Date
February 05, 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 |