Steins

Basic Information

• Brand Name: Steins
• Primary DI: 00041298993865
• Version / Model: 765-3080-0000
• Company Name: D-M-S HOLDINGS, INC.
• Labeler DUNS: 062028220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-02
• Public Version: 1
• Public Version Date: 2024-02-12
• Public Version Status: New
• Public Device Record Key: 26780533-1a57-43fc-836c-6f8d25c49683

Device Description

Stein's Gel Bunion Toe Separators

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: Yes

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
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
Package	10041298993862	GS1	Master carton	250	In Commercial Distribution
Primary	00041298993865	GS1