Duns Number:021717889
Device Description: Single Use Air/Water and Suction Valves
Catalog Number
SUV-618-01
Brand Name
Orca®
Version/Model Number
SUV-618-01
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ODC
Product Code Name
Endoscope channel accessory
Public Device Record Key
61e9cc82-8814-4899-b600-d8bf63d5e036
Public Version Date
May 24, 2019
Public Version Number
1
DI Record Publish Date
May 16, 2019
Package DI Number
08714729993698
Quantity per Package
50
Contains DI Package
08714729993728
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |