Guardenia

GUDID 05391530440134

Tissue extraction bag

Primary Device ID	05391530440134
NIH Device Record Key	ee50c832-79a3-4e81-906b-71856e98a3ad
Commercial Distribution Status	In Commercial Distribution
Brand Name	Guardenia
Version Model Number	GAR-1
Company DUNS	989586482
Company Name	ADVANCED SURGICAL CONCEPTS LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	05391530440127 [Primary]
GS1	05391530440134 [Package] Contains: 05391530440127 Package: carton of 5 [5 Units] In Commercial Distribution

GCJ	Laparoscope, General & Plastic Surgery

Steralize Prior To Use	false
Device Is Sterile	true

05391530440134 - Guardenia	2021-12-17The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. A system for the containment of tissue for reduction, with a scalpel (or similar instrument), and extraction. The device will retract the incision & contain the tissue being extracted. The device will provide protection of the containment component from inadvertent damage from sharp instruments used in the reduction process.
05391530440134 - Guardenia	2021-12-17 The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/o
05391530440011 - PneumoLiner	2018-07-06 The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive
05391530440066 - TriPort+	2018-07-06 This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. T
05391530440097 - TriPort15	2018-07-06 This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. T
05391530440103 - QuadPort+	2018-07-06 This device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic sur

Mark Image Registration \| Serial	Company Trademark Application Date
GUARDENIA 90854153 not registered Live/Pending	Olympus Corporation 2021-07-28