DARCO® Commodus Open CO4

GUDID 10609271000190

XL Black

DARCO INTERNATIONAL, INC.

Orthotic shoe, non-customized

• Primary Device ID: 10609271000190
• NIH Device Record Key: d6389d68-a6c5-4d01-ba1f-b07a44736402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DARCO® Commodus Open
• Version Model Number: CO4
• Catalog Number: CO4
• 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	00609271000193 [Primary]
GS1	10609271000190 [Package]; Contains: 00609271000193; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271000197 [Package]; Contains: 00609271000193; Package: Case [36 Units]; In Commercial Distribution

FDA Product Code

• KNP: ORTHOSIS, CORRECTIVE SHOE

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

On-Brand Devices [DARCO® Commodus Open]

• 10609271000190: XL Black
• 20609271000180: L Black
• 10609271000176: M Black
• 10609271000169: S Black
• 20609271000159: XS Black