Guardenia

GUDID 05391530440134

The 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.

ADVANCED SURGICAL CONCEPTS LIMITED

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• 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

Customer Support Contacts

• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie
• Phone: +35312864777
• Email: info@advancedsurgical.ie

Device Identifiers

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

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211234

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-17
• Device Publish Date: 2021-12-09

Devices Manufactured by ADVANCED SURGICAL CONCEPTS LIMITED

• 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