DARCO® Foot Filament FF

GUDID 00609271000094

DARCO INTERNATIONAL, INC.

Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical

• Primary Device ID: 00609271000094
• NIH Device Record Key: 9086ac66-c783-4f8b-a7ad-4b48382d8c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DARCO® Foot Filament
• Version Model Number: FF
• Catalog Number: FF
• Company DUNS: 184231298
• Company Name: DARCO INTERNATIONAL, 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: true
• 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	00609271000094 [Primary]

FDA Product Code

• GXB: ESTHESIOMETER

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: 2023-02-16
• Device Publish Date: 2023-02-08

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