Duo™ Pro Wound Care shoe DP4B

GUDID 10609271999319

black (extra-large)

DARCO INTERNATIONAL, INC.

Orthotic shoe, non-customized

• Primary Device ID: 10609271999319
• NIH Device Record Key: 51ff4c7f-4fb9-406e-a5af-ef5d2120469c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duo™ Pro Wound Care shoe
• Version Model Number: DP4B
• Catalog Number: DP4B
• 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	00609271999312 [Primary]
GS1	10609271999319 [Package]; Contains: 00609271999312; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271999316 [Package]; Contains: 00609271999312; 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: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [Duo™ Pro Wound Care shoe]

• 20609271999323: black (2X-large)
• 10609271999319: black (extra-large)
• 10609271999302: black (large)
• 20609271999293: black (medium)
• 10609271999289: black (small)
• 20609271999279: black (extra-small)