DEVICE: SJM™ (05415067009678)

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Device Identifier (DI) Information

SJM™
Masters Series Mechanical Heart Valve
A-RHR
ST. JUDE MEDICAL, INC.
05415067009678
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Heart valve prosthesis holder, single-use A sterile surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring in place during its implantation with sutures. The holder may be grasped by the outside of its stem using forceps; it is removed from the valve when suturing is completed. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DTJ HOLDER, HEART-VALVE, PROSTHESIS
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: May store indefinitely.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 04, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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