CS-10-30-300 OpClear Disposable

Basic Information

• Brand Name: CS-10-30-300 OpClear Disposable
• Primary DI: 50603468008448
• Version / Model: CS-10-30-300
• Catalog Number: CS-10-30-300
• Company Name: CIPHER SURGICAL LIMITED
• Labeler DUNS: 216734283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-01
• Public Version: 2
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: 1bce9a3d-9d7d-4c51-b6f8-e5cc204de606

Device Description

The OpClear Disposable is a 10mm (Diameter) x 300 mm (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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	876.1500	2
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63646	Surgical irrigation pump	An electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).	No	Active
61204	Endoscope lens cleaner, gas/fluid, single-use	A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50603468009674	GS1	Box Carton	10	In Commercial Distribution
Primary	50603468008448	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius