FDA.reportPublic FDA data

CS-10-30-300 OpClear Disposable

Primary DI
50603468009674
Brand
CS-10-30-300 OpClear Disposable
Company
CIPHER SURGICAL LIMITED
Model
CS-10-30-300
Catalog number
CS-10-30-300
Device description
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.
Published
2021-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171637000OpClear SystemCipher Surgical, Ltd.2018-02-26OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50603468009674PackageGS110In Commercial Distribution
50603468008448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060346800967450603468009674
5060346800844850603468008448

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation pumpAn electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
216734283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
50603468009292CS-05-30-300 OpClear DisposableCS-05-30-300CS-05-30-3002022-12-22
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

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