T FOAM CUBE XSOFT YELLOW 2 INX1.75 INX3 IN 18/BX

Basic Information

• Brand Name: T FOAM CUBE XSOFT YELLOW 2 INX1.75 INX3 IN 18/BX
• Primary DI: 00733657221060
• Version / Model: 5087
• Catalog Number: 2970001875
• Company Name: ALIMED, INC.
• Labeler DUNS: 056007248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 18
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 3
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: 554dd769-7723-4d71-ac1c-a89c54b9e376

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
ION	EXERCISER, NON-MEASURING	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34200	Finger/hand exerciser	A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733657221060	GS1
Unit of Use	00733657299069	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]