Spex Limited

Basic Information

• Brand Name: Spex Limited
• Primary DI: 09420051709683
• Version / Model: 9420051709683
• Company Name: SPEX LIMITED
• Labeler DUNS: 748649195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-26
• Public Version: 1
• Public Version Date: 2024-10-04
• Public Version Status: New
• Public Device Record Key: 5cb044eb-484e-4e3c-977d-3782dc9241d2

Device Description

Stylo 160 Fixed Standard Mechanism

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41119	Wheelchair/chair/stander headrest	A padded device attached to a wheelchair, a disability-supportive chair, and/or a stander to provide a disabled patient with additional head support and comfort while in a sitting and/or standing position. This device will also include the extensions (e.g., a metal insert, screws) needed to attach this device. It may be available in various shapes and sizes, and it may be adjustable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051709683	GS1

Customer Contacts

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