CARBOMEDICS PROSTHETIC HEART VALVES

Primary DI
08022057014030
Brand
CARBOMEDICS PROSTHETIC HEART VALVES
Company
CORCYM SRL
Model
RM-399
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOPRotator, prosthetic heart valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOPRotator, Prosthetic Heart ValveCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951368000CARBOMEDICS EXENDED MITRAL ROTATORCarbomedics, Inc.1995-06-20MOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08022057014030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057014030080220570140308022057014030

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis sizer handleA hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
441454802
Device count
1
Lot or batch
true
Sterilization required before use
true

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08022057016027Memo 4D Curve4DC384DC382026-07-04
08022057016034Memo 4D Curve4DC404DC402026-07-04
08022057016041Memo 4D Curve4DC424DC422026-07-04
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