McCarus-Volker FORNISEE® System - Set of 4 FS® SOUNDS 6 cm, 8 cm, 10 cm, and 12 - LSI Solutions, Inc.

Duns Number:603420183

Device Description: Set of 4 FS® SOUNDS 6 cm, 8 cm, 10 cm, and 12 cmBase Package Type - KitOne (1) each non-st Set of 4 FS® SOUNDS 6 cm, 8 cm, 10 cm, and 12 cmBase Package Type - KitOne (1) each non-sterile, reusable 6 cm, 8 cm, 10 cm, 12 cm FS® SOUNDS Set of Four (4) for use with the McCarus-Volker FORNISEE® System.

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More Product Details

Catalog Number

110112

Brand Name

McCarus-Volker FORNISEE® System

Version/Model Number

110112

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111014

Product Code Details

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Device Record Status

Public Device Record Key

c653dbac-c0c0-484e-91a4-26406d42749c

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LSI SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 31