CS-CU15-03 OpClear Control Unit

FDA UDI

Class II (US FDA UDI)

by Cipher Surgical, Ltd.

Identity

Trade Name: CS-CU15-03 OpClear Control Unit FDA UDI
Generic Name: Endoscope lens cleaner, gas/fluid, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: CS-CU15-03 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: CS-CU15-03 FDA UDI
Primary DI / UDI-DI: 50603468003184 FDA UDI
FDA Product Code: OCX FDA UDI
FEQ FDA UDI
GMDN Term: Endoscope lens cleaner, gas/fluid, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope lens cleaner, gas/fluid, single-use Surgical irrigation pump

CS-CU15-03 OpClear Control Unit by Cipher Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation pump.

BEAMER AVEO IRRIGATION PUMP HEAD REPLACEMENT PART — Chongqing Jinshan Science & Technology (Group) Co., Ltd · Class II
Wellead Portable Roller Irrigation Pump — Well Lead Medical Co., Ltd · Class II
Torrent — US Endoscopy · Class II
Wellead Portable Roller Irrigation Pump — Well Lead Medical Co., Ltd · Class II
Sutter — Sutter Medizintechnik GmbH · Class II
Wellead Portable Roller Irrigation Pump — Well Lead Medical Co., Ltd · Class II
FUJIFILM — FUJIFILM Corporation · Class II
joimax® — JOIMAX, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cipher Surgical, Ltd.

Sources (1)

FDA UDI cd96583d-4ae6-4e7b-a784-ccf858076579 36 fields · synced Jun 6, 2026