DEVICE: CoRoent (00887517274205)

Device Identifier (DI) Information

CoRoent
6006860
In Commercial Distribution

Nuvasive, Inc.
00887517274205
GS1

1
053950783 *Terms of Use
CoRoent® XL+, 6x18x60mm
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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
Intracardiac circulatory assist axial-pump catheter control unit A mains electricity (AC-powered) device designed to operate and monitor an intracardiac circulatory assist axial-pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It typically consists of operator controls, a monitoring interface, a low-voltage connection to drive the impeller, a fluid purging pump, and provides backup power when line power is not available during transport. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary.
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081611 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c61e5605-d586-4791-9a41-a3c4e7f2d846
July 06, 2018
3
October 26, 2016
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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
No
No CLOSE

Customer Contact

[?]
+1(858)909-1800
RA_UDI@nuvasive.com
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