CS-SR10-00 OpClear Disposable CS-SR10-00

GUDID 50603468007830

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.

CIPHER SURGICAL LIMITED

Surgical irrigation pump
Primary Device ID50603468007830
NIH Device Record Key07242ab6-b0e8-4730-83b0-02a94e218c9a
Commercial Distribution Discontinuation2022-05-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCS-SR10-00 OpClear Disposable
Version Model NumberCS-SR10-00
Catalog NumberCS-SR10-00
Company DUNS216734283
Company NameCIPHER SURGICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com
Phone+4402477170700
Emailcustomerservice@ciphersurgical.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS150603468007076 [Primary]
GS150603468007830 [Package]
Contains: 50603468007076
Package: Box Carton [10 Units]
Discontinued: 2022-05-01
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEQPump, Air, Non-Manual, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-07-04
Device Publish Date2019-07-08

Devices Manufactured by CIPHER SURGICAL LIMITED

50603468006840 - CS-SZ10-00 OpClear Disposable2022-07-04 The OpClear Disposable is a 10mm x00degree x 314mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which
50603468006918 - CS-SZ10-30 OpClear Disposable2022-07-04 The OpClear Disposable is a 10mm x30degree x 314mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which
50603468007830 - CS-SR10-00 OpClear Disposable2022-07-04The 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.
50603468007830 - CS-SR10-00 OpClear Disposable2022-07-04 The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which
50603468007762 - CS-SR10-30 OpClear Disposable2022-07-04 The OpClear Disposable is a 10mm x30degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which
50603468007908 - CS-OS10-00 OpClear Disposable2022-07-04 The OpClear Disposable is a 10mm x00degree x 300mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which
50603468009506 - CS-10-00-300 OpClear Disposable2021-10-11 The OpClear Disposable is a 10mm (diameter) x 300mm (L) x 0 degree angled sterile, invasive, single use device which is fitted
50603468009674 - CS-10-30-300 OpClear Disposable2021-10-11 The OpClear Disposable is a 10mm (Diameter) x 300 mm (L) x angled (30 and 45 degrees compatible) sterile, invasive, single use d
50603468009742 - CS-10-00-315 OpClear Disposable2021-10-11 The OpClear Disposable is a 10mm (Diameter) x 315mm (L) x 0 degree angled sterile, invasive, single use device which is fitted t

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