FDA.report

MEMO 3D

Primary DI
08022057013156
Brand
MEMO 3D
Company
SORIN GROUP ITALIA SRL
Model
SMD
Published
2015-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KRHRING, ANNULOPLASTY

Product Code Classifications

CodeDeviceSpecialtyClass
KRHRing, AnnuloplastyCardiovascular2

Premarket Submissions

SubmissionSupplement
K071327000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K071327000MEMO 3D SEMIRIGID ANNULOPLASTY RINGSorin Biomedica Cardio S.R.L.2007-08-10KRH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08022057013156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08022057013156080220570131568022057013156

GMDN Terms

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
428011907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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38033178102934DHF02 HEMOCONCENTRATOR2015-07-15
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38033178233638SH14 - HEMOCONCENTRATOR2015-07-15
38033178019621Aortic Root cannulaAR-131142026-03-06
38033178019638Aortic Root cannulaAR-191142026-03-06
38033178019645Vessel CannulaVC-120002026-03-06
38033178019652Vessel CannulaVC-120102026-03-06
38033178019669Vessel CannulaVC-120202026-03-06
38033178019676Vessel CannulaVC-220102026-03-06
38033178017191Cardioplegia CannulaAR-110122026-02-11
38033178017207Cardioplegia CannulaAR-110142026-02-11
38033178017214Cardioplegia CannulaAR-110162026-02-11
38033178017221Cardioplegia CannulaAR-110182026-02-11
38033178017238Cardioplegia CannulaAR-111122026-02-11
38033178017245Cardioplegia CannulaAR-111142026-02-11
38033178017252Cardioplegia CannulaAR-111162026-02-11
38033178017269Cardioplegia CannulaAR-170122026-02-11
38033178017276Cardioplegia CannulaAR-170142026-02-11
38033178017313Cardioplegia CannulaAX-303212026-02-11
38033178018075Coronary Sinus CannulaRCM-141152026-02-11

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