FertiloScope

GUDID 05060508530046

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

FERTILITY FOCUS LIMITED

Laparoscopic access cannula, single-use

• Primary Device ID: 05060508530046
• NIH Device Record Key: a0817c5c-2f65-4827-85ab-5fa32831afe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FertiloScope
• Version Model Number: FTO 1.40
• Company DUNS: 347449352
• Company Name: FERTILITY FOCUS LIMITED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060508530046 [Primary]

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

[05060508530046]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-09
• Device Publish Date: 2018-10-17

Devices Manufactured by FERTILITY FOCUS LIMITED

• 05060508530107 - OvuSense: 2021-08-02 OvuSense 2 App - iOS
• 05060508530114 - OvuSense: 2021-08-02 OvuSense 2 App - Android
• 05060508530091 - OvuSense: 2021-05-10 M426 OvuFirst Skin Worn Sensor
• 05060508530121 - OvuSense: 2021-05-10 M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
• 05060508530046 - FertiloScope: 2020-01-09Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy
• 05060508530046 - FertiloScope: 2020-01-09 Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvagina
• 05060508530039 - OvuSense: 2018-03-29 M300 NFC OvuSense Starter Pack - OvuSense Personal Sensor M026, OvuSense App and M028 NFC Reader
• 05060508530053 - OvuSense NFC Sensor: 2018-03-29 M026 OvuSense NFC Sensor