Health Design Ankle Leg Walker HD-LWS-MM3

GUDID 10609271000831

Large Black

DARCO INTERNATIONAL, INC.

Lower-limb orthosis ankle/foot component

• Primary Device ID: 10609271000831
• NIH Device Record Key: 432e60bf-bd41-4534-88d2-87fe6b82b329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Design Ankle Leg Walker
• Version Model Number: HD-LWS-MM3
• Catalog Number: HD-LWS-MM3
• 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	00609271000834 [Primary]
GS1	10609271000831 [Package]; Contains: 00609271000834; Package: Box [4 Units]; In Commercial Distribution
GS1	20609271000838 [Package]; Contains: 00609271000834; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• NOC: Splint, extremity, non-inflatable, external, non-sterile

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 [Health Design Ankle Leg Walker]

• 20609271000845: Extra-Large Black
• 10609271000831: Large Black
• 20609271000821: Medium Black
• 20609271000814: Small Black
• 10609271000800: Extra-Small Black