AccessGUDID - DEVICE: FertiloScope (05060508530046)

GUDID

Device Identifier (DI) Information

Brand Name: FertiloScope
Version or Model: FTO 1.40
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VIO HEALTHTECH LIMITED

Primary DI Number: 05060508530046
Issuing Agency: GS1
Commercial Distribution End Date: February 10, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 347449352 *Terms of Use

Device Description: Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy

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):	No
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
HIH	Hysteroscope (And Accessories)
HEW	Culdoscope (And Accessories)
HET	Laparoscope, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: a0817c5c-2f65-4827-85ab-5fa32831afe5
Public Version Date: January 31, 2023
Public Version Number: 5
DI Record Publish Date: October 17, 2018