AccessGUDID - DEVICE: WayPoint™ Burr Hole Entry Marker Tool (00873263003008)

GUDID

Device Identifier (DI) Information

Brand Name: WayPoint™ Burr Hole Entry Marker Tool
Version or Model: 66-MP-EM-00300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66-MP-EM
Company Name: FHC, INC.

Primary DI Number: 00873263003008
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: WayPoint Burr Hole Entry Marker Tool 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?
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
Moist Heat or Steam Sterilization
Ethylene Oxide

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: 431e25e7-1473-4051-bacd-b4a92eda1567
Public Version Date: December 18, 2018
Public Version Number: 4
DI Record Publish Date: September 17, 2016