Orpyx Sensory Insoles 10185571000356

GUDID 10185571000356

The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support

Orpyx

Pressure monitoring insole

• Primary Device ID: 10185571000356
• NIH Device Record Key: 95788e2c-a7ec-458e-b1af-210dcd95be24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orpyx Sensory Insoles
• Version Model Number: ORPYXSIV1
• Catalog Number: 10185571000356
• Company DUNS: 250917031
• Company Name: Orpyx
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10185571000356 [Primary]

FDA Product Code

• IRN: Device, Warning, Overload, External Limb, Powered

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: 2025-02-17
• Device Publish Date: 2025-02-07

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