Duns Number:216734283
Device Description: The OpClear Control Unit is a mains powered medical device which supplies, on demand, CO2 The OpClear Control Unit is a mains powered medical device which supplies, on demand, CO2 to the distal lens of the laparoscope via the OpClear Disposable. Includes a footswitch which is integral to the operation of the device.
Catalog Number
CS-CU15-03
Brand Name
CS-CU15-03 OpClear Control Unit
Version/Model Number
CS-CU15-03
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171637,K171637
Product Code
FEQ
Product Code Name
Pump, Air, Non-Manual, For Endoscope
Public Device Record Key
cd96583d-4ae6-4e7b-a784-ccf858076579
Public Version Date
July 16, 2019
Public Version Number
1
DI Record Publish Date
July 08, 2019
Package DI Number
50603468008066
Quantity per Package
1
Contains DI Package
50603468003184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |