Duns Number:989586482
Device Description: The Guardenia contained extraction system is indicated to contain and isolate tissue durin 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.
Catalog Number
-
Brand Name
Guardenia
Version/Model Number
GAR-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K211234,K211234
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
ee50c832-79a3-4e81-906b-71856e98a3ad
Public Version Date
December 17, 2021
Public Version Number
1
DI Record Publish Date
December 09, 2021
Package DI Number
05391530440134
Quantity per Package
5
Contains DI Package
05391530440127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton of 5
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |