Steins

GUDID 10041298993862

Stein's Gel Bunion Toe Separators

D-M-S HOLDINGS, INC.

Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator Toe separator

• Primary Device ID: 10041298993862
• NIH Device Record Key: 26780533-1a57-43fc-836c-6f8d25c49683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steins
• Version Model Number: 765-3080-0000
• Company DUNS: 062028220
• Company Name: D-M-S HOLDINGS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041298993865 [Primary]
GS1	10041298993862 [Package]; Contains: 00041298993865; Package: Master carton [250 Units]; In Commercial Distribution

FDA Product Code

• KYS: Insoles, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Steins]

• 10041298994050: Stein's Comfort Insoles - Large
• 10041298994043: Stein's Comfort Insoles - Medium
• 10041298994036: Stein's Comfort Insoles - Small
• 10041298993862: Stein's Gel Bunion Toe Separators