DEVICE: NVM5 (00887517097071)

Device Identifier (DI) Information

NVM5
1545456
In Commercial Distribution

Nuvasive, Inc.
00887517097071
GS1

1
053950783 *Terms of Use
NVM5 Cranial Array, SSEP
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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
Electromyographic needle electrode, single-use A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
IKN Electromyograph, diagnostic
ETN STIMULATOR, NERVE
GWF STIMULATOR, ELECTRICAL, EVOKED RESPONSE
OLO Orthopedic stereotaxic instrument
HAW Neurological stereotaxic Instrument
PDQ Neurosurgical nerve locator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143641 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

da4e6ce8-b2ab-403c-b9c9-79fe52895822
July 06, 2018
4
October 13, 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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