McCarus-Volker FORNISEE® System

GUDID 10850200006220

FS-35 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patient use disposable FS-35 FORNISEE® Device, uterine manipulator, for use only with the McCarus-Volker FORNISEE® System. 35 mm Cervical Cup

LSI Solutions, Inc.

Uterine manipulator, single-use

• Primary Device ID: 10850200006220
• NIH Device Record Key: ab81cbb6-c266-4046-9bb3-4ed4ee49c128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McCarus-Volker FORNISEE® System
• Version Model Number: 110035
• 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: 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: 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006223 [Primary]
GS1	10850200006220 [Package]; Contains: 00850200006223; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111014

FDA Product Code

• HEW: Culdoscope (And Accessories)
• LKF: Cannula, manipulator/injector, uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• 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