DEVICE: PULSE (00887517990808)
Device Identifier (DI) Information
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 |
OWB | Interventional fluoroscopic x-ray system |
HAW | Neurological stereotaxic Instrument |
PDQ | Neurosurgical nerve locator |
OLO | Orthopedic stereotaxic instrument |
GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
LLZ | System, image processing, radiological |
JAA | System, x-ray, fluoroscopic, image-intensified |
ETN | STIMULATOR, NERVE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K180038 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1c8f83ef-cd7e-4c41-a3d6-69623e07e1c7
July 18, 2019
1
July 10, 2019
July 18, 2019
1
July 10, 2019
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 |
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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