AccessGUDID - DEVICE: CardioCel 3D (09348992000358)

GUDID

Device Identifier (DI) Information

Brand Name: CardioCel 3D
Version or Model: UC0406A60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C0406A60
Company Name: ADMEDUS REGEN PTY LTD

Primary DI Number: 09348992000358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 741172167 *Terms of Use

Device Description: CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35273	Cardiovascular patch, animal-derived	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PSQ	Intracardiac Patch Or Pledget, Biologically Derived

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170951	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 4 Centimeter
Length: 6 Centimeter
Angle: 60 degree

Device Record Status

Public Device Record Key: 447edb62-970a-4624-a6ed-a94a462ae4fc
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: September 07, 2018