CIPHER SURGICAL LIMITED

Address:The Venture Centre,Coventry,GB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Endoscopic Irrigation/Suction System (OCX) (10) Pump, Air, Non-Manual, For Endoscope (FEQ) (10)

Premarket Exempt

Clear

CS-CU15-03 OpClear Control Unit - 50603468003184 Catalog Number : CS-CU15-03

Device Description : The OpClear Control Unit is a mains powered medical device which supplies, on de 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.

Device Class :

Duns Number: 216734283

Premarket Exempt : No

Product Code : OCX, FEQ

Prescription Use : Yes

Device Count : 1

CS-SZ10-00 OpClear Disposable - 50603468006840 Catalog Number : CS-SZ10-00

Device Description : The OpClear Disposable is a 10mm x00degree x 314mm (L) sterile, invasive, single The OpClear Disposable is a 10mm x00degree x 314mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.

Device Class :

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-SZ10-30 OpClear Disposable - 50603468006918 Catalog Number : CS-SZ10-30

Device Description : The OpClear Disposable is a 10mm x30degree x 314mm (L) sterile, invasive, single The OpClear Disposable is a 10mm x30degree x 314mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.

Device Class :

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-SR10-00 OpClear Disposable - 50603468007076 Catalog Number : CS-SR10-00

Device Description : The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single 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.

Device Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-SR10-30 OpClear Disposable - 50603468007144 Catalog Number : CS-SR10-30

Device Description : The OpClear Disposable is a 10mm x30degree x 328mm (L) sterile, invasive, single The OpClear Disposable is a 10mm x30degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.

Device Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-OS10-00 OpClear Disposable - 50603468007212 Catalog Number : CS-OS10-00

Device Description : The OpClear Disposable is a 10mm x00degree x 300mm (L) sterile, invasive, single The OpClear Disposable is a 10mm x00degree x 300mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.

Device Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-10-00-300 OpClear Disposable - 50603468008370 Catalog Number : CS-10-00-300

Device Description : The OpClear Disposable is a 10mm (diameter) x 300mm (L) x 0 degree angled steri The OpClear Disposable is a 10mm (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 Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-10-30-300 OpClear Disposable - 50603468008448 Catalog Number : CS-10-30-300

Device Description : The OpClear Disposable is a 10mm (Diameter) x 300 mm (L) x angled (30 and 45 deg 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 Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-10-00-315 OpClear Disposable - 50603468008516 Catalog Number : CS-10-00-315

Device Description : The OpClear Disposable is a 10mm (Diameter) x 315mm (L) x 0 degree angled steril The OpClear Disposable is a 10mm (Diameter) x 315mm (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 Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

CS-10-30-315 OpClear Disposable - 50603468008684 Catalog Number : CS-10-30-315

Device Description : The OpClear Disposable is a 10mm (Diameter) x 315mm (L) x angled (30 and 45 degr The OpClear Disposable is a 10mm (Diameter) x 315mm (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 Class : 2

Duns Number: 216734283

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

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