AccessGUDID - DEVICE: microTargeting™ WayPoint™ Inserter Kit (00873263003367)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ WayPoint™ Inserter Kit
Version or Model: 66-WP-ID-01-00336
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66-WP-ID-01
Company Name: FHC, INC.

Primary DI Number: 00873263003367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting WayPoint Inserter Kit, 130mm, for use with 66-WP-MR kit and microTargeting Platform

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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 [?]
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
Length: 130 Millimeter

Device Record Status

Public Device Record Key: dcc456e7-913f-4815-a923-75e3302336b7
Public Version Date: June 08, 2021
Public Version Number: 6
DI Record Publish Date: September 17, 2016