Spex

Basic Information

• Brand Name: Spex
• Primary DI: 09420051706828
• Version / Model: 1266-3048-800
• Catalog Number: 1266-3048-800
• Company Name: SPEX LIMITED
• Labeler DUNS: 748649195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: dc5fc15c-46a7-4ddc-844a-bf809e57da15

Device Description

Axial Biangular Lateral Pad Size 8, with 12mm Pressure Reduction padding, Comfy-cover

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
45887	Wheelchair head/trunk support, prefabricated	A prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051706828	GS1

Customer Contacts

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