FDA.reportPublic FDA data

CryoPatch® SG Pulmonary Human Cardiac Trunk Patch

Primary DI
00877234000478
Brand
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
Company
Artivion, Inc.
Model
SGP010
Catalog number
SGP010
Device description
CryoPatch SG Pulmonary TrunkThe CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Published
2015-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K101866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101866000CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHCryolife, Inc.2010-07-23DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234000478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234000478008772340004788772340004780877234000478

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric pulmonary artery bioprosthesisA non-sterile, implantable, heart tissue allograft obtained from a human cadaver intended to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00At or Below -135 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-419-3355xxx@xx.xx

Regulatory Flags#

DUNS number
119253177
Device count
1
HCT/P
true
Serial number
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumPFP1X14PFP1X142026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumPFP8X14PFP8X142026-05-29
00877234000096CardioGenesisNS2000LSR-SG2100S2016-12-12
00877234000447CryoValve® SG Pulmonary Human Heart Valve SGPV00SGPV002015-09-11
00877234000454CryoValve® SG Pulmonary Human Heart Valve SGPV10SGPV102015-09-11
00877234000102CardioGenesisHP-SG3HP-SG32016-12-12
00877234001192"AMDS Hybrid Prosthesis (""AMDS"")"K039420AMDS40 2025-02-05
00877234001208"AMDS Hybrid Prosthesis (""AMDS"")"K039421AMDS4030 2025-02-05
00877234001215"AMDS Hybrid Prosthesis (""AMDS"")"K039422AMDS55 2025-02-05
00877234001222"AMDS Hybrid Prosthesis (""AMDS"")"K039423AMDS55402025-02-05
00877234001321"AMDS Hybrid Prosthesis (""AMDS"")"K038896AMDS4030c 2025-02-05
00877234001338"AMDS Hybrid Prosthesis (""AMDS"")"K038895AMDS40c 2025-02-05
10877234001298BioGlue Surgical AdhesiveBG3510-5-USBG3510-5-US2024-03-13
10877234001304BioGlue Surgical AdhesiveBG3515-5-USBG3515-5-US2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
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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
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