CS-05-00-300 OpClear Disposable

Basic Information

• Brand Name: CS-05-00-300 OpClear Disposable
• Primary DI: 50603468009124
• Version / Model: CS-05-00-300
• Catalog Number: CS-05-00-300
• Company Name: CIPHER SURGICAL LIMITED
• Labeler DUNS: 216734283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-22
• Public Version: 1
• Public Version Date: 2022-12-30
• Public Version Status: New
• Public Device Record Key: c0e4e30e-44f0-4b73-8111-46a4d889a80b

Device Description

The OpClear Disposable is a 5mm (Diameter) x 300mm (L) x 0 degree angled 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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50603468010328	GS1		10	In Commercial Distribution
Primary	50603468009124	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221824	000

Storage Conditions

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