FloShield/Plus FSB-02-1045

GUDID 00815128020584

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.

MINIMALLY INVASIVE DEVICES, INC.

Endoscope lens cleaner, gas/fluid, single-use Endoscope lens cleaner, gas/fluid, single-use
Primary Device ID00815128020584
NIH Device Record Key8c8f6e69-2cec-4c44-8b7f-9f4b615622f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloShield/Plus
Version Model NumberFSB-02-1045
Catalog NumberFSB-02-1045
Company DUNS793517660
Company NameMINIMALLY INVASIVE DEVICES, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-614-340-3349
Emailinquiries@floshield.com
Phone1-614-340-3349
Emailinquiries@floshield.com

Device Dimensions

Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter
Lumen/Inner Diameter10 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Fahrenheit and 115 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815128020584 [Primary]
GS110815128020581 [Package]
Package: Sales Box [6 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2016-07-25

On-Brand Devices [FloShield/Plus]

00815128020751The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020744The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020607FTS1 FloShield/Plus Tube Set is an accessory for 5mm FloShield and 10mm FloShield systems and on
00815128020591The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020584The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020577The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020560The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020553The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020546The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020539The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020522The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
10815128020512The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020508The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
10815128020499The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020485The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020478The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020461The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020454The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020447The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020430The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020423The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020416The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
10815128020406The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020393The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020386The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020379The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020362The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020355The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020348The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020331The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020324The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
10815128020314The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
00815128020300The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.