Health Design Low Profile Cast Boot HD-CB-TP2

GUDID 20609271000517

Small/Medium Black

DARCO INTERNATIONAL, INC.

Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot Cast boot

• Primary Device ID: 20609271000517
• NIH Device Record Key: a696c735-ba7b-4dc3-b29b-07913021bcce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Design Low Profile Cast Boot
• Version Model Number: HD-CB-TP2
• Catalog Number: HD-CB-TP2
• 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	00609271000513 [Primary]
GS1	10609271000510 [Package]; Contains: 00609271000513; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271000517 [Package]; Contains: 00609271000513; Package: Case [36 Units]; In Commercial Distribution

FDA Product Code

• IPG: SHOE, CAST

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 Low Profile Cast Boot]

• 10609271000558: Extra-Large Black
• 20609271000548: Large Black
• 10609271000534: Medium/Large Black
• 20609271000524: Medium Black
• 20609271000517: Small/Medium Black
• 10609271000503: Small Black