Therastep Heel Cups

Basic Information

• Brand Name: Therastep Heel Cups
• Primary DI: 00614464070167
• Version / Model: 7016
• Company Name: Silipos Holding LLC
• Labeler DUNS: 056112948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-24
• Public Version: 1
• Public Version Date: 2022-09-01
• Public Version Status: New
• Public Device Record Key: 19e03a8e-5981-4a10-a5f8-e1e2eabb8c2c

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: Yes
• 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
KYS	Insoles, Medical	General Hospital	880.6280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59098	Orthotic insole, prefabricated, antimicrobial	A prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614464070167	GS1