Spex Limited

Basic Information

• Brand Name: Spex Limited
• Primary DI: 09420051710948
• Version / Model: 1256-1616-0SS_090
• Company Name: SPEX LIMITED
• Labeler DUNS: 748649195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-13
• Public Version: 1
• Public Version Date: 2023-11-21
• Public Version Status: New
• Public Device Record Key: 70806bf3-a271-419c-9a04-15a863623e3e

Device Description

Supershape Back Support, 16" Wide x 16" High with adjustable shape and contour system - Granite Grey

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
KNN	Components, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36254	Wheelchair back rest	A padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051710948	GS1

Customer Contacts

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