Spex

Basic Information

• Brand Name: Spex
• Primary DI: 09420051706224
• Version / Model: 1275-0062-000
• Catalog Number: 1275-0062-000
• 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: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 4bba0905-f4c3-4959-8c8a-08264a9ed435

Device Description

Spex Adjustable Lateral 250 Head Support Head Support pad

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 headrest	A padded device attached to a wheelchair, typically with a long and sturdy metal insert, to provide the wheelchair occupant with a support upon which to rest the head. The device improves user comfort and may improve some user range of vision. Its exterior is typically made of tear-resistant polyurethane. This GMDN code will also include the extensions needed to attach this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051706224	GS1

Customer Contacts

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