DEVICE: Corox (04035479112165)

Device Identifier (DI) Information

Corox
OTW-L 75-BP
In Commercial Distribution
368345
BIOTRONIK SE & Co. KG
04035479112165
GS1

1
315620229 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60910 Coronary venous pacing lead
An 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OJX Drug eluting permanent left ventricular (lv) pacemaker electrode
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P070008 015
P070008 070
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Special Storage Condition, Specify: Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
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Clinically Relevant Size

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

7872f057-48ad-4dd5-82b5-95eaf2ed8905
February 05, 2021
4
August 08, 2014
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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

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