FDA.reportPublic FDA data

SJM™

Primary DI
05414734007542
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
SARP-36
Catalog number
SARP-36
Device description
For Mitral Valve Repair
Published
2014-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K092310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092310000SEGUIN ANNULOPLASTY RINGSt Jude Medical2009-08-27KRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734007542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734007542054147340075425414734007542

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
Outer Diameter36Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in the double-barrier pouch in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16
05415067031600Navitor™NVTR-29NVTR-292023-01-16
05415067010728Portico™PRT-23PRT-232021-09-20
05415067012487Portico™PRT-25PRT-252021-09-20
05415067012494Portico™PRT-27PRT-272021-09-20
05415067012500Portico™PRT-29PRT-292021-09-20
05415067031914Aveir™LSL02LSL022023-03-03
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08022057015952Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015969Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015976Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015983Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057015990Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016003Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016010Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016027Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016034Memo 4D CurveCORCYM SRLKRH2026-07-04
08022057016041Memo 4D CurveCORCYM SRLKRH2026-07-04
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