FDA.reportPublic FDA data

CardioCel 3D Cardiovascular Patch

Primary DI
09348992000648
Brand
CardioCel 3D Cardiovascular Patch
Company
ADMEDUS REGEN PTY LTD
Model
UC0406A
Catalog number
C0406A
Device description
CardioCel® 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.
Published
2020-04-16
Public version status
Update
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
PSQIntracardiac Patch Or Pledget, Biologically Derived

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSQIntracardiac Patch Or Pledget, Biologically DerivedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170951000CardioCel 3DAdmedus Regen Pty, Ltd.2017-04-28PSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348992000648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348992000648093489920006489348992000648

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle60degree
Length6Centimeter
Width4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61892660100info@admedus.com

Regulatory Flags#

DUNS number
741172167
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348992000006CardioCelUC0202C02022015-09-17
09348992000013CardioCelUC0404C04042015-09-17
09348992000020CardioCelUC0508C05082015-09-17
09348992000037CardioCel UC0614C06142015-09-17
09348992000082CardioCelUC0208C02082015-09-17
09348992000105CardioCel VSDUC0202C02022016-07-13
09348992000143CardioCel NeoUC0404NC04042016-10-17
09348992000150CardioCel NeoUC0508NC05082016-10-17
09348992000181CardioCel AgileUC0404AC04042016-10-17
09348992000198CardioCel AgileUC0508AC05082016-10-17
09348992000228CardioCel ClosureUC0610CC06102016-10-17
09348992000235CardioCel ClosureUC0614CC06142016-10-17
09348992000266VascuCelUV0880V08802016-10-21
09348992000273VascuCelUV2080V20802016-10-21
09348992000280CardioCel 3DUC0406AC0406A2017-05-09
09348992000303VascuCelUV1014V10142017-09-08
09348992000327CardioCel 3DUC0307A90C0307A902018-09-07
09348992000334CardioCel 3DUC0405A30C0405A302018-09-07
09348992000341VascuCel 3DUV1206TV1206T2018-09-07
09348992000358CardioCel 3DUC0406A60C0406A602018-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001635PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00850023375087CardiaMendHelios Cardio Inc.PSQ2023-07-07
00085412818313Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818375Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818597Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818610Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818658Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818672Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818696Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00850023375063CardiaMendHelios Cardio Inc.PSQ2022-12-13
00850023375070CardiaMendHelios Cardio Inc.PSQ2022-12-13
00085412818474Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818498Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818511Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818535Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818559Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818573Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818634Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00850023375001CardiaMendHelios Cardio Inc.PSQ2022-02-01
00850023375018CardiaMendHelios Cardio Inc.PSQ2022-02-01