AccessGUDID - DEVICE: WayPoint™ Target Offset Mounting Hub (00873263003107)

GUDID

Device Identifier (DI) Information

Brand Name: WayPoint™ Target Offset Mounting Hub
Version or Model: 66-MP-TH-00310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66-MP-TH
Company Name: FHC, INC.

Primary DI Number: 00873263003107
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: WayPoint Target Offset Mounting Hub, 6mm offset, for use with microTargeting Platform

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:	No
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?
46863	Neurosurgical micro targeting drive	A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.	Active	false
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 [?]
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54e05f93-ca0f-4623-8325-6e9ac189b864
Public Version Date: December 19, 2018
Public Version Number: 4
DI Record Publish Date: September 17, 2016