FDA.reportPublic FDA data

CS-05-30-300 OpClear Disposable

Primary DI
50603468009292
Brand
CS-05-30-300 OpClear Disposable
Company
CIPHER SURGICAL LIMITED
Model
CS-05-30-300
Catalog number
CS-05-30-300
Device description
The OpClear Disposable is a 5mm (Diameter) x 300mm (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.
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221824000OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315Cipher Surgical Limited2022-08-19OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50603468010496PackageGS110In Commercial Distribution
50603468009292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060346801049650603468010496
5060346800929250603468009292

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope lens cleaner, gas/fluid, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4402477170700customerservice@ciphersurgical.com

Regulatory Flags#

DUNS number
216734283
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50603468008998CS-05-00-290 OpClear DisposableCS-05-00-290CS-05-00-2902022-12-22
50603468009056CS-05-30-290 OpClear DisposableCS-05-30-290CS-05-30-2902022-12-22
50603468009124CS-05-00-300 OpClear DisposableCS-05-00-300CS-05-00-3002022-12-22
50603468009360CS-05-00-315 OpClear DisposableCS-05-00-315CS-05-00-3152022-12-22
50603468009438CS-05-30-315 OpClear DisposableCS-05-30-315CS-05-30-3152022-12-22
50603468003184CS-CU15-03 OpClear Control UnitCS-CU15-03CS-CU15-032019-07-08
50603468008370CS-10-00-300 OpClear DisposableCS-10-00-300CS-10-00-3002021-10-01
50603468008448CS-10-30-300 OpClear DisposableCS-10-30-300CS-10-30-3002021-10-01
50603468008516CS-10-00-315 OpClear DisposableCS-10-00-315CS-10-00-3152021-10-01
50603468008684CS-10-30-315 OpClear DisposableCS-10-30-315CS-10-30-3152021-10-01
50603468008752CS-10-00-330 OpClear DisposableCS-10-00-330CS-10-00-3302021-10-01
50603468008820CS-10-30-330 OpClear DisposableCS-10-30-330CS-10-30-3302021-10-01
50603468007076CS-SR10-00 OpClear DisposableCS-SR10-00CS-SR10-002019-07-08
50603468007144CS-SR10-30 OpClear DisposableCS-SR10-30CS-SR10-302019-07-08
50603468007212CS-OS10-00 OpClear DisposableCS-OS10-00CS-OS10-002019-07-08
50603468006840CS-SZ10-00 OpClear DisposableCS-SZ10-00CS-SZ10-002019-07-08
50603468006918CS-SZ10-30 OpClear DisposableCS-SZ10-30CS-SZ10-302019-07-08
50603468007830CS-SR10-00 OpClear DisposableCS-SR10-00CS-SR10-002019-07-08
50603468007762CS-SR10-30 OpClear DisposableCS-SR10-30CS-SR10-302019-07-08
50603468007908CS-OS10-00 OpClear DisposableCS-OS10-00CS-OS10-002019-07-08

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