FloShield 10mm Endoscopic Cannula FRT-10C

GUDID 00815128020669

The reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator is an access device indicated for use with a disposable 8.5 – 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

MINIMALLY INVASIVE DEVICES, INC.

Laparoscopic trocar blade, reusable
Primary Device ID00815128020669
NIH Device Record Key522e658e-a504-4962-8008-20751758e2c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloShield 10mm Endoscopic Cannula
Version Model NumberFRT-10C
Catalog NumberFRT-10C
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815128020669 [Primary]
GS110815128020666 [Package]
Package: Pouch [1 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815128020669]

Moist Heat or Steam Sterilization


[00815128020669]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-25

Devices Manufactured by MINIMALLY INVASIVE DEVICES, INC.

00815128020003 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
10815128020017 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
10815128020024 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
00815128020034 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
10815128020048 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
00815128020058 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
00815128020065 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
00815128020072 - FloShield/Air2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.