FDA.report

CardioGRAFT-MC™

Primary DI
00889858013239
Brand
CardioGRAFT-MC™
Company
LIFENET HEALTH
Model
DPPGK5530
Catalog number
DPPGK5530
Device description
Decell Pulmonary Patch - Thick
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

Related Records

Contact Domains

Product Codes

CodeName
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications

CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889858013239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889858013239008898580132398898580132390889858013239

GMDN Terms

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

TypeValueUnit
Length55Millimeter
Width30Millimeter

Sterilization Methods

Method

Contacts

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

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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 DIBrandCompanyProduct codePublished
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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
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