FDA.reportPublic FDA data

CardioGRAFT-MC™

Primary DI
00889858014274
Brand
CardioGRAFT-MC™
Company
LIFENET HEALTH
Model
DPPGN3530
Catalog number
DPPGN3530
Device description
Decell Pulmonary Patch - Thin
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889858014274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889858014274008898580142748898580142740889858014274

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric pulmonary artery bioprosthesisAn 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
Length35Millimeter
Width30Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-847-7831xx@xx.xx

Regulatory Flags#

DUNS number
121828156
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
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
00889858640800PliaFX FloBL-2200-00BL-2200-002025-01-01
00889858640817PliaFX FloBL-2200-01BL-2200-012025-01-01
00889858640824PliaFX FloBL-2200-02BL-2200-022025-01-01
00889858640831PliaFX FloBL-2200-05BL-2200-052025-01-01
00889858640848PliaFX FloBL-2200-10BL-2200-102025-01-01
00889858640855PliaFX FloBL-2225-00BL-2225-002025-01-01
00889858640862PliaFX FloBL-2225-01BL-2225-012025-01-01
00889858640879PliaFX FloBL-2225-02BL-2225-022025-01-01
00889858640886PliaFX FloBL-2225-05BL-2225-052025-01-01
00889858640893PliaFX FloBL-2225-10BL-2225-102025-01-01
00889858640244ViviGen MIS Delivery SystemBL-1925-001BL-1925-0012024-02-15
00889858638562FlexiGRAFT®FDL0951902023-01-31
00889858608459FlexiGRAFT®FGLTS08565FGLTS2018-08-01
00889858608466FlexiGRAFT®FGLTS08566FGLTS2018-08-01
00889858608473FlexiGRAFT®FGLTS08567FGLTS2018-08-01
00889858608480FlexiGRAFT®FGLTS08568FGLTS2018-08-01
00889858608497FlexiGRAFT®FGLTS08569FGLTS2018-08-01
00889858608503FlexiGRAFT®FGLTS08570FGLTS2018-08-01
00889858608510FlexiGRAFT®FGLTS08571FGLTS2018-08-01
00889858608527FlexiGRAFT®FGLTS08572FGLTS2018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589795950241PeriBeam® Pericardial MembraneTAMABIO CO., LTD.DXZ2026-03-17
00840663110551CardioCel Bioscaffold Patch 4 cm X 4 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110568CardioCel Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110575CardioCel Bioscaffold Patch 6 cm X 14 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110605CardioCel Neo Bioscaffold Patch 4 cm X 4 cm Lemaitre Vascular, Inc.DXZ2024-10-10
00840663110667VascuCel Bioscaffold Patch .8 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110674VascuCel Bioscaffold Patch 1 cm X 14 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110773CardioCel Neo Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110544CardioCel Bioscaffold Patch 2 cm X 2 cmLemaitre Vascular, Inc.DXZ2024-10-08
20705031462202ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462219ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462226ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462233ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462240ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462257ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462264ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462271ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462288ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462301ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462318ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462325ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462332ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462349ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462356ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462363ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462370ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462387ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462394ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462400ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
30705031239788ETHIBOND EXCELETHICON, LLCDXZ2018-01-31