FDA.reportPublic FDA data

MOSAIC ULTRA®

Primary DI
00613994479259
Brand
MOSAIC ULTRA®
Company
MEDTRONIC, INC.
Model
305U221
Device description
VALVE 305U221 MOS AOR ULT CINCHII US
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWRheart-valve, non-allograft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWRHeart-Valve, Non-Allograft TissueUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990064007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990064007MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVEMedtronic, Inc.2000-07-14DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994479259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994479259006139944792596139944792590613994479259

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103220223TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
08022057014696PERCEVALCORCYM SRLLWR2025-05-09
08022057014702PERCEVALCORCYM SRLLWR2025-05-09
08022057014719PERCEVALCORCYM SRLLWR2025-05-09
08022057014726PERCEVALCORCYM SRLLWR2025-05-09
08022057015365PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015372PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015389PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015396PERCEVAL PLUSCORCYM SRLLWR2025-05-07
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926519Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926526Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000647025Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647032Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647049Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647056Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647063Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647070Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
05415067045447Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045454Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045461Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045478Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
08022057015532Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015549Perceval RELYON PAK CORCYM SRLLWR2022-11-11