FUJIFILM

GUDID 04547410447866

The product is comprised of a minimally invasive surgical trocar (Outer sheath sleeve, Inner trocar and Optical obturator) and accessories (Lens cleaning syringe and Lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insuf ation and the other attached to the Inner trocar is used for the objective lens cleaning function. The design of the InterLock Trocar maintains the laparoscope and the hand instrument in direct alignment. This feature provides a surgeon with control of the laparoscope image and the hand instrument with one hand, meaning the laparoscope is in direct alignment or parallel to the hand instrument. The hand instrument is always in the eld of view of the laparoscope. The laparoscope does not need to be held by another surgeon or health care personnel. The InterLock Trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparosco

FUJIFILM CORPORATION

Laparoscopic access cannula, single-use

• Primary Device ID: 04547410447866
• NIH Device Record Key: c3f0deba-b0a6-4f05-90f7-efab00224fde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUJIFILM
• Version Model Number: DLT05S
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856853006009 [Previous]
GS1	04547410447866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170084

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2020-12-17
• Device Publish Date: 2020-12-09

On-Brand Devices [FUJIFILM]

• 04547410366051: This product is intended to be used in combination with FUJIFILM gastrointestinal endoscopes and
• 04547410366044: This product is intended for use in combination with FUJIFILM 700 system scopes to deliver air a
• 14547410358695: This device is intended for the visualization of the lower digestive tract, specifically for the
• 14547410358688: This device is intended for the visualization of the lower digestive tract, specifically for the
• 14547410358671: The device is intended for the visualization of the upper digestive tract, specifically for the
• 04547410358667: The device is intended for the visualization of the upper digestive tract, specifically for the
• 14547410343202: This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea
• 04547410343052: This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of
• 04547410342741: The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ult
• 04547410341294: This device is intended for the visualization of the lower digestive tract, specifically for the
• 04547410341287: This device is intended for the visualization of the lower digestive tract, specifically for the
• 04547410339437: This product is the suction button used in combination with our endoscopes in medical facilities
• 04547410339420: This product is the suction button used in combination with our endoscopes in medical facilities
• 04547410337730: The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image rec
• 04547410337419: The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording.
• 04547410337402: The device is intended for the visualization of the upper digestive tract, specifically for the
• 04547410337396: This device is intended for the visualization of the lower digestive tract, specifically for the
• 04547410334999: Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
• 04547410334982: Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
• 04547410334616: Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c
• 04547410334609: Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c
• 04547410334593: Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
• 04547410334586: Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
• 04547410334579: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334562: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334555: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334548: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334531: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334524: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334517: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334500: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410334494: Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
• 04547410333435: This product is intended to seal the acoustic coupling medium when used with Fujinon/Fujifilm ul
• 04547410333312: This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea
• 04547410333305: This device is intended for the visualization of the lower digestive tract, specifically for the
• 04547410333299: This device is intended for the visualization of the lower digestive tract, specifically for the
• 04547410332377: The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr
• 04547410332360: The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji
• 04547410332353: The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr
• 04547410332346: The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji
• 04547410332100: This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
• 04547410332094: This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
• 04547410332063: This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
• 14547410331674: These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
• 14547410331667: These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
• 14547410331650: These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
• 04547410331646: The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower
• 04547410331639: This device is intended for the visualization of the upper digestive tract, specifically for the
• 04547410331608: This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestina
• 04547410331592: This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestina