AccessGUDID - DEVICE: FUJIFILM (04547410447866)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: DLT05S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410447866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use
Previous DI: 00856853006009

Device Description: 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 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":	No
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?
42412	Laparoscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170084	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3f0deba-b0a6-4f05-90f7-efab00224fde
Public Version Date: June 11, 2024
Public Version Number: 2
DI Record Publish Date: December 09, 2020