Duns Number:216734283
Device Description: The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use acces The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.
Catalog Number
CS-SR10-00
Brand Name
CS-SR10-00 OpClear Disposable
Version/Model Number
CS-SR10-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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
07242ab6-b0e8-4730-83b0-02a94e218c9a
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
July 08, 2019
Package DI Number
50603468007830
Quantity per Package
10
Contains DI Package
50603468007076
Package Discontinue Date
May 01, 2022
Package Status
Not 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 |