WayPoint™ Sterilization Case

Basic Information

• Brand Name: WayPoint™ Sterilization Case
• Primary DI: 00873263003374
• Version / Model: 66-WP-SC-00337
• Catalog Number: 66-WP-SC
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 5
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 16a402e6-af9d-4ad7-977b-fd5962246f63

Device Description

WayPoint Sterilization Case, 1x, nonsterile

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42997	Surgical instrument/implant rack	A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00873263001738	GS1
Primary	00873263003374	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092192	000