Steins

GUDID 10041298994043

Stein's Comfort Insoles - Medium

D-M-S HOLDINGS, INC.

Orthotic insole, prefabricated, non-antimicrobial

• Primary Device ID: 10041298994043
• NIH Device Record Key: ac71f684-af6f-4164-a106-47dffde8c571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steins
• Version Model Number: 765-8700-0002
• 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	00041298994046 [Primary]
GS1	10041298994043 [Package]; Contains: 00041298994046; Package: [50 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
• 10041298994227: Stein’s Metatarsal Pads - Clear (4/pk)
• 10041298994210: Stein’s Metatarsal Pads - Black (4/pk)
• 10041298994203: Stein’s Metatarsal Pads - Brown (4/pk)