FDA.reportPublic FDA data

FloShield 10mm Conical Blunt Obturator

Primary DI
00815128020683
Brand
FloShield 10mm Conical Blunt Obturator
Company
MINIMALLY INVASIVE DEVICES, INC.
Model
FRT-10D
Catalog number
FRT-10D
Device description
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.
Published
2016-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815128020680PackageGS11In Commercial Distribution
00815128020683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512802068010815128020680
00815128020683008151280206838151280206830815128020683

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-614-340-3349inquiries@floshield.com

Regulatory Flags#

DUNS number
793517660
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815128020652Flo-XFX10FX102016-07-25
00815128020010FloShield/AirFSS-02-0500TFSS-02-0500T2016-07-25
00815128020027FloShield/AirFSB-02-0500TFSB-02-0500T2016-07-25
00815128020041FloShield/AirFSS-02-0530TFSS-02-0530T2016-07-25
00815128020119FloShield/AirFSS-03-1000TFSS-03-1000T2016-07-25
00815128020133FloShield/AirFSB-01-1000TFSB-01-1000T2016-07-25
00815128020317FloShield/PlusFSS-02-0500FSS-02-05002016-12-12
00815128020409FloShield/PlusFSS-02-1000FSS-02-10002016-12-12
00815128020492FloShield/PlusFSS-04-1030FSS-04-10302016-12-12
00815128020515FloShield/PlusFSB-02-1030FSB-02-10302016-12-12
00815128020003FloShield/AirFSS-01-0500TFSS-01-0500T2016-07-25
10815128020017FloShield/AirFSS-02-0500TFSS-02-0500T2016-07-25
10815128020024FloShield/AirFSB-02-0500TFSB-02-0500T2016-07-25
00815128020034FloShield/AirFSS-01-0530TFSS-01-0530T2016-07-25
10815128020048FloShield/AirFSS-02-0530TFSS-02-0530T2016-07-25
00815128020058FloShield/AirFSB-02-0530TFSB-02-0530T2016-07-25
00815128020065FloShield/AirFSS-01-0545TFSS-01-0545T2016-07-25
00815128020072FloShield/AirFSS-02-0545TFSS-02-0545T2016-07-25
00815128020089FloShield/AirFSB-02-0545TFSB-02-0545T2016-07-25
00815128020096FloShield/AirFSS-01-1000TFSS-01-1000T2016-07-25

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