CS-10-00-315 OpClear Disposable CS-10-00-315

GUDID 50603468009742

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.

CIPHER SURGICAL LIMITED

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• Primary Device ID: 50603468009742
• NIH Device Record Key: ab08bc53-f74f-4a5e-898f-4c9759836ebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS-10-00-315 OpClear Disposable
• Version Model Number: CS-10-00-315
• Catalog Number: CS-10-00-315
• Company DUNS: 216734283
• Company Name: CIPHER SURGICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com
• Phone: +4402477170700
• Email: customerservice@ciphersurgical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	50603468008516 [Primary]
GS1	50603468009742 [Package]; Contains: 50603468008516; Package: Box Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171637

FDA Product Code

• FEQ: Pump, Air, Non-Manual, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-01

Devices Manufactured by CIPHER SURGICAL LIMITED

• 50603468006840 - CS-SZ10-00 OpClear Disposable: 2022-07-04 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 Disposable: 2022-07-04 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 Disposable: 2022-07-04 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 Disposable: 2022-07-04 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 Disposable: 2022-07-04 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 Disposable: 2021-10-11 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 Disposable: 2021-10-11 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 Disposable: 2021-10-11The 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.
• 50603468009742 - CS-10-00-315 OpClear Disposable: 2021-10-11 The OpClear Disposable is a 10mm (Diameter) x 315mm (L) x 0 degree angled sterile, invasive, single use device which is fitted t