"Therastep Gel Toe Separators, French/English, 2pcs/blister "

Basic Information

• Brand Name: "Therastep Gel Toe Separators, French/English, 2pcs/blister "
• Primary DI: 00614464070532
• Version / Model: 7053
• Company Name: Silipos Holding LLC
• Labeler DUNS: 056112948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: b7908cb7-aba4-42e9-be08-3b774740a0f0

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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13544	Toe separator	A foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614464070532	GS1