FDA.reportPublic FDA data

CardioCel Closure

Primary DI
09348992000488
Brand
CardioCel Closure
Company
ADMEDUS REGEN PTY LTD
Model
UC0610C
Catalog number
C0610
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
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130872000CARDIOCELCelxcel Pty, Ltd.2014-01-30DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348992000488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348992000488093489920004889348992000488

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
Length6Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage 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
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
14026704634504DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-21
14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646767DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646798DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646804DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
00859389005102Tyke, Patch, Pledget and IntracardiacElutia Med LLCDXZ2019-02-28
14026704638540DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638557DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638564DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638571DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638588DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638601DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638618DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638663DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704634818DEKNATELTELEFLEX INCORPORATEDDXZ2018-07-30