AccessGUDID - DEVICE: CS-SZ10-30 OpClear Disposable (50603468006918)

GUDID

Device Identifier (DI) Information

Brand Name: CS-SZ10-30 OpClear Disposable
Version or Model: CS-SZ10-30
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CS-SZ10-30
Company Name: CIPHER SURGICAL LIMITED

Primary DI Number: 50603468006918
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 216734283 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61204	Endoscope lens cleaner, gas/fluid, single-use	A 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.	Active	false
63646	Surgical irrigation pump	An 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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEQ	Pump, Air, Non-Manual, For Endoscope
OCX	Endoscopic Irrigation/Suction System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171637	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b4fa5a3-ac5e-483b-aa75-25c23b5e5f9c
Public Version Date: July 04, 2022
Public Version Number: 2
DI Record Publish Date: July 08, 2019