Duns Number:961027315
Device Description: Ruhof; ScopeValet; Eco Bedside Kit; Bedside Sponge with Bio-Clean Technology
Catalog Number
G4SVECO
Brand Name
CARDINAL HEALTH
Version/Model Number
G4SVECO
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"
Yes
For Single-Use
Yes
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
MNL
Product Code Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Public Device Record Key
36ee33b6-51c4-4181-ade9-5fe99635152d
Public Version Date
April 18, 2019
Public Version Number
1
DI Record Publish Date
April 10, 2019
Package DI Number
50885380070073
Quantity per Package
50
Contains DI Package
10885380070075
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |