DEVICE: Corox (04035479093532)

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Device Identifier (DI) Information

Corox
OTW 75-BP
354805
BIOTRONIK SE & Co. KG
04035479093532
GS1
1
No description.
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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
Coronary venous pacing lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. 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
OJX Drug eluting permanent left ventricular (lv) pacemaker electrode
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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
Special Storage Condition, Specify: Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
Storage Environment Temperature: less than 77 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Length: 77 cm
Device Size Text, specify: Max. Diameter: 1.95 mm
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Device Status

In Commercial Distribution
August 06, 2014

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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
No
No CLOSE

Customer Contact

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+1(888)345-0374
jon.brumbaugh@biotronik.com
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