Guardenia

Primary DI
05391530440127
Brand
Guardenia
Company
ADVANCED SURGICAL CONCEPTS LIMITED
Model
GAR-1
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.
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211234000RedExAdvanced Surgical Concepts, Ltd.2021-09-17GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530440134PackageGS15In Commercial Distribution
05391530440127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530440134053915304401345391530440134
05391530440127053915304401275391530440127

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn 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.

Contacts#

Phone, Email table
PhoneEmail
+35312864777info@advancedsurgical.ie

Regulatory Flags#

DUNS number
989586482
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530440004PneumoLinerWA90500US2016-09-19
05391530440134GuardeniaGAR-12021-12-09
05391530440073TriPort+WA58010T2016-09-13
05391530440110QuadPort+WA58010Q2016-09-13
05391530440011PneumoLinerWA90500US2016-09-19
05391530440066TriPort+WA58010T2016-09-13
05391530440097TriPort15WA58015T2016-09-13
05391530440103QuadPort+WA58010Q2016-09-13

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Primary DI, Brand, Company table
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00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29