FloShield/Plus - The FloShield/Plus System is a single-use, - MINIMALLY INVASIVE DEVICES, INC.

Duns Number:793517660

Device Description: The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intend The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.

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More Product Details

Catalog Number

FSS-03-1045

Brand Name

FloShield/Plus

Version/Model Number

FSS-03-1045

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"

Yes

For Single-Use

Yes

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

-

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

9585dd05-304a-4fb0-996a-59efd4e9c2c5

Public Version Date

April 09, 2019

Public Version Number

3

DI Record Publish Date

July 25, 2016

Additional Identifiers

Package DI Number

10815128020550

Quantity per Package

6

Contains DI Package

00815128020553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Box

"MINIMALLY INVASIVE DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16