FDA.reportPublic FDA data

ProxiCor for Pericardial Closure

Primary DI
10859389005017
Brand
ProxiCor for Pericardial Closure
Company
AZIYO BIOLOGICS, INC.
Model
CMCV-060-402
Device description
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Published
2015-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K051405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051405000REGENSIS PERICARDIAL PATCHCormatrix Cardiovascular, Inc.2005-08-31DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859389005017PackageGS15In Commercial Distribution
00859389005010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085938900501710859389005017
00859389005010008593890050108593890050100859389005010

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
Height15Centimeter
Width7Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
470-514-4080xxx@xx.xx

Regulatory Flags#

DUNS number
080251450
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479160647Biotronik BioEnvelope4405792019-08-26
10859389005109Tyke, Patch, Pledget and IntracardiacCMCV-098-2042019-02-28
10859389005116CanGaroo EnvelopeCMCV-009-XXL2019-02-28
10859389005024CanGaroo EnvelopeCMCV-009-SML2015-07-01
10859389005031CanGaroo EnvelopeCMCV-009-MED2015-07-01
10859389005062CanGaroo EnvelopeCMCV-009-LRG2015-07-01
10859389005079CanGaroo EnvelopeCMCV-009-XLG2015-07-01
10859389005048ProxiCor for Cardiac Tissue RepairCMCV-064-4012015-06-30
10859389005055ProxiCor for Cardiac Tissue RepairCMCV-067-4042015-07-01
10859389005086VasCure for Carotid RepairCMCV-072-6062015-07-01
10859389005093VasCure for Carotid RepairCMCV-073-6092015-07-01
10859389005123VasCure for Vascular RepairCMCV-011-6062015-07-01
10859389005147VasCure for Vascular RepairCMCV-013-6092015-07-01

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