FDA.report

EDWARDS BOVINE PERICARDIAL PATCH

Primary DI
00690103144178
Brand
EDWARDS BOVINE PERICARDIAL PATCH
Company
Edwards Lifesciences LLC
Model
4700
Catalog number
4700
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

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
00690103144178PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
57460691952770TRUWAVEPXMK1077PXMK10772026-03-20
57460691955887TRUWAVEPXMK1780PXMK17802026-03-20
00690103000382SWAN-GANZ TRUE SIZE123F6123F6P2026-03-16
50690103218287SWAN-GANZ VIP831F75831F75P2026-03-16
50690103218607SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
50690103218621SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
50690103218638SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL20A9631PL20A2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL23A9631PL23A2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL26A9631PL26A2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL29A9631PL29A2026-02-17
00690103019353AORTIC TRUE-SIZE OBTURATOR 19MM1161116119MM2026-02-13
00690103019360AORTIC TRUE-SIZE OBTURATOR 21MM1161116121MM2026-02-13
00690103019377AORTIC TRUE-SIZE OBTURATOR 23MM1161116123MM2026-02-13
00690103019384AORTIC TRUE-SIZE OBTURATOR 25MM1161116125MM2026-02-13
00690103019391AORTIC TRUE-SIZE OBTURATOR 27MM1161116127MM2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MM1161116129MM2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MM1161116131MM2026-02-13
00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11

Other Devices Sharing Product Codes

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
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