AccessGUDID - DEVICE: WayPoint™ Implantation Kit (00873263005330)

GUDID

Device Identifier (DI) Information

Brand Name: WayPoint™ Implantation Kit
Version or Model: 66-WP-RU-00533
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66-WP-RU
Company Name: FHC, INC.

Primary DI Number: 00873263005330
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Combination Bit WayPoint Driver 4mm

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 [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0d773e25-6391-4935-8a21-79485ba68762
Public Version Date: October 31, 2018
Public Version Number: 4
DI Record Publish Date: October 10, 2016