ProSplints

GUDID 00802357130320

MEDICAL SPECIALTIES INCORPORATED

Multiple-joint lower limb orthosis

• Primary Device ID: 00802357130320
• NIH Device Record Key: aedadec7-161b-4333-839c-dcb7b6ee1eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSplints
• Version Model Number: 113032
• 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	00802357130320 [Primary]

FDA Product Code

• IQI: Orthosis, Limb 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 [ProSplints]

• 00802357137442: 113744
• 00802357137435: 113743
• 00802357137411: 113741
• 00802357132805: 113280
• 00802357130719: 113071
• 00802357130702: 113070
• 00802357130542: 113054
• 00802357130528: 113052
• 00802357130511: 113051
• 00802357130344: 113034
• 00802357130320: 113032
• 00802357130313: 113031
• 00802357130115: 113011
• 00802357130108: 113010