McCarus-Volker FORNISEE® System

GUDID 00850200006360

8 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 8 cm FS® SOUND for use with the McCarus-Volker FORNISEE® System.

LSI Solutions, Inc.

Uterine sound, reusable

• Primary Device ID: 00850200006360
• NIH Device Record Key: bcf04277-6988-4a99-a271-7a5f1c01a0cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McCarus-Volker FORNISEE® System
• Version Model Number: 110058
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 866-575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter
• Length: 8 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111014

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00850200006360]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [McCarus-Volker FORNISEE® System]

• 00850200006391: Set of 4 FS® SOUNDS 6 cm, 8 cm, 10 cm, and 12 cm Base Package Type - Kit One (1) each non-steri
• 00850200006384: 12 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 12 cm FS® SOUND for use
• 00850200006377: 10 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 10 cm FS® SOUND for use
• 00850200006360: 8 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 8 cm FS® SOUND for use w
• 00850200006322: 6 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 6 cm FS® SOUND for use w
• 00850200006261: Combo Box of 6 FS FORNISEE® DEVICES Base Package Type - Kit The combo box contains two (2) each
• 10850200006237: FS-40 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien
• 10850200006220: FS-35 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien
• 10850200006213: FS-30 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien