Guardenia

Basic Information

• Brand Name: Guardenia
• Primary DI: 05391530440127
• Version / Model: GAR-1
• Company Name: ADVANCED SURGICAL CONCEPTS LIMITED
• Labeler DUNS: 989586482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-09
• Public Version: 1
• Public Version Date: 2021-12-17
• Public Version Status: New
• Public Device Record Key: ee50c832-79a3-4e81-906b-71856e98a3ad

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45130	Tissue extraction bag	An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391530440134	GS1	carton of 5	5	In Commercial Distribution
Primary	05391530440127	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211234	000