TroClose1200™

GUDID 27290017191014

Single Use Cannula with Integrated Port Closure System for use *only* with a TroClose1200™ Obturator (found in REF# GSTC1200)

GORDIAN SURGICAL LTD

Laparoscopic access cannulation/wound closure set
Primary Device ID27290017191014
NIH Device Record Key6210de8a-97da-44a6-a3ca-dde36f7c2192
Commercial Distribution StatusIn Commercial Distribution
Brand NameTroClose1200™
Version Model NumberGSTC1200C
Company DUNS600087854
Company NameGORDIAN SURGICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-619-467-3426
EmailTroClose@GordianSurgical.com

Device Dimensions

Length115 Millimeter
Lumen/Inner Diameter12 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017191010 [Primary]
GS117290017191017 [Package]
Contains: 07290017191010
Package: Shelf box [6 Units]
In Commercial Distribution
GS127290017191014 [Package]
Contains: 17290017191017
Package: Shipping box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-07-06
Device Publish Date2017-12-07

On-Brand Devices [TroClose1200™]

27290017191014Single Use Cannula with Integrated Port Closure System for use *only* with a TroClose1200™ Obt
17290017191000Gordian TroClose1200™ Integrated Port Closure System

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