Spex

Basic Information

• Brand Name: Spex
• Primary DI: 09420051707047
• Version / Model: 1266-3031-400
• Catalog Number: 1266-3031-400
• 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: eca4fbb3-e713-43cc-a634-483e63c53784

Device Description

Broad lateral pad with standard cover, size 1; 105mm high x 130mm deep (when purchased with lateral bracket)

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
46887	Lead IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of lead in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051707047	GS1

Customer Contacts

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