Duns Number:216734283
Device Description: The OpClear Disposable is a 10mm (Diameter) x 330mm (L) x angled (30 and 45 degrees compa The OpClear Disposable is a 10mm (Diameter) x 330mm (L) x angled (30 and 45 degrees compatible) sterile, invasive, single use device which is fitted to a compatible laparoscope and used with the OpClear Control Unit.
Catalog Number
CS-10-30-330
Brand Name
CS-10-30-330 OpClear Disposable
Version/Model Number
CS-10-30-330
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)
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
a914ddf6-2858-4f98-9e48-b65c00ae7882
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
Package DI Number
50603468010014
Quantity per Package
10
Contains DI Package
50603468008820
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |