DEVICE: microTargeting™ Platform Accessory (00873263004135)
Device Identifier (DI) Information
microTargeting™ Platform Accessory
MP-KIT-MB-00413
Not in Commercial Distribution
MP-KIT-MB
FHC, INC.
MP-KIT-MB-00413
Not in Commercial Distribution
MP-KIT-MB
FHC, INC.
Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
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? |
---|---|---|---|---|
32568 | Neurological 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 neurosurgery. 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 |
---|---|
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092192 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity |
Storage Environment Temperature: between -34 and 57 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 13 Millimeter |
Device Record Status
6e81bd99-641a-4462-806e-f5c1d5ad939d
October 17, 2023
5
September 17, 2016
October 17, 2023
5
September 17, 2016
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(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com