Phantom Dorsal NIght Splint with Toe Strap

GUDID 00802357000197

MEDICAL SPECIALTIES INCORPORATED

Foot orthosis

• Primary Device ID: 00802357000197
• NIH Device Record Key: f3908d03-88af-4974-987a-b69c5c282ddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phantom Dorsal NIght Splint with Toe Strap
• Version Model Number: 264126-T
• Company DUNS: 003173028
• Company Name: MEDICAL SPECIALTIES INCORPORATED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• 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	00802357000197 [Primary]

FDA Product Code

• ITW: Joint, Ankle, External Brace

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Phantom Dorsal NIght Splint with Toe Strap]

• 00802357000203: 264127-T
• 00802357000197: 264126-T
• 00802357000180: 264125-T
• 00802357000173: 264124-T
• 00802357000166: 264122-T