Health Design Low Profile Cast Boot HD-CB-TP6

GUDID 10609271000558

Extra-Large Black

DARCO INTERNATIONAL, INC.

Cast boot

• Primary Device ID: 10609271000558
• NIH Device Record Key: 40257142-9ddf-4e79-9461-97e3284aa523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Design Low Profile Cast Boot
• Version Model Number: HD-CB-TP6
• Catalog Number: HD-CB-TP6
• 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	00609271000551 [Primary]
GS1	10609271000558 [Package]; Contains: 00609271000551; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271000555 [Package]; Contains: 00609271000551; 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