AccessGUDID - DEVICE: microTargeting™ Platform (00873263004241)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Platform
Version or Model: MP-KIT-P-U3-00424
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MP-KIT-P-U3
Company Name: FHC, INC.

Primary DI Number: 00873263004241
Issuing Agency: GS1
Commercial Distribution End Date: June 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient customized.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9f5ba92-ecd3-4406-ae52-09c86bb37707
Public Version Date: June 24, 2019
Public Version Number: 5
DI Record Publish Date: September 17, 2016