DEVICE: OPTISURE¿™ (05414734507172)

Device Identifier (DI) Information

OPTISURE¿™
LDA210-65
In Commercial Distribution
LDA210-65
ST. JUDE MEDICAL, INC.
05414734507172
GS1

1
790268031 *Terms of Use
Defibrillation Lead
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Endocardial defibrillation lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
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FDA Product Code

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Product Code Product Code Name
NVY Permanent defibrillator electrodes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P950022 085
P950022 110
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Length: 65 Centimeter
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Device Record Status

e098b848-23ba-4255-9054-8715a0ccd0ef
July 06, 2018
3
April 10, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

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