FDA.reportPublic FDA data

CardioCel 3D

Primary DI
09348992000549
Brand
CardioCel 3D
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
2019-03-21
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
09348992000549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348992000549093489920005499348992000549

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