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 Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use
Primary Device ID10850200006220
NIH Device Record Keyab81cbb6-c266-4046-9bb3-4ed4ee49c128
Commercial Distribution StatusIn Commercial Distribution
Brand NameMcCarus-Volker FORNISEE® System
Version Model Number110035
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006223 [Primary]
GS110850200006220 [Package]
Contains: 00850200006223
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEWCuldoscope (And Accessories)
LKFCannula, manipulator/injector, uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-09-23

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

00850200006391Set of 4 FS® SOUNDS 6 cm, 8 cm, 10 cm, and 12 cm Base Package Type - Kit One (1) each non-steri
0085020000638412 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 12 cm FS® SOUND for use
0085020000637710 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 10 cm FS® SOUND for use
008502000063608 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 8 cm FS® SOUND for use w
008502000063226 cm FS® SOUND Base Package Type - Each One (1) non-sterile, reusable 6 cm FS® SOUND for use w
00850200006261Combo Box of 6 FS FORNISEE® DEVICES Base Package Type - Kit The combo box contains two (2) each
10850200006237FS-40 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien
10850200006220FS-35 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien
10850200006213FS-30 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patien

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