DEVICE: PULSE (00195377099013)
Device Identifier (DI) Information
PULSE
8000104
In Commercial Distribution
Nuvasive, Inc.
8000104
In Commercial Distribution
Nuvasive, Inc.
PULSE Software Package including IOM, iG
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45200 | Orthopaedic stereotactic surgery system |
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IKN | Electromyograph, diagnostic |
LLZ | System, image processing, radiological |
PDQ | Neurosurgical nerve locator |
GWF | Stimulator, electrical, evoked response |
OWB | Interventional fluoroscopic x-ray system |
OLO | Orthopedic stereotaxic instrument |
HAW | Neurological stereotaxic Instrument |
ETN | STIMULATOR, NERVE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K210574 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4ca7b68b-0ef0-4e39-809b-e5698b2b82aa
July 14, 2023
1
July 06, 2023
July 14, 2023
1
July 06, 2023
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(858)909-1800
RA_UDI@nuvasive.com
RA_UDI@nuvasive.com