FDA.reportPublic FDA data

PROFILE 3D®

Primary DI
00613994759221
Brand
PROFILE 3D®
Company
MEDTRONIC, INC.
Model
680R32
Device description
RING 680R32 PROFILE 3D 26L MEXICO
Published
2015-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRHRING, ANNULOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRHRing, AnnuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073324000MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680RMedtronic, Inc.2008-03-13KRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994759221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994759221006139947592216139947592210613994759221

GMDN Terms#

Term, Definition table
TermDefinition
Mitral annuloplasty ringA sterile circular band intended to be implanted in the heart for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Heat
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

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
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000659301SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659318SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659325SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659332SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659349SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659356SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659363SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659370SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659387SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659394SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659400SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659417SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659424SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659431SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659448SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659455SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659462SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659509Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659516Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659523Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659530Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659547Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659554Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659561Tri-Ad™MEDTRONIC, INC.KRH2026-02-01
00763000659202SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659219SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659226SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659233SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659240SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659257SimuForm™MEDTRONIC, INC.KRH2026-02-01