Health Design Polycast Cast Boot HD-CB-PC1

GUDID 20609271000401

Pediatric Black

DARCO INTERNATIONAL, INC.

Cast boot

• Primary Device ID: 20609271000401
• NIH Device Record Key: cca5f193-1460-45c8-8322-ceb9cce6eee6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Design Polycast Cast Boot
• Version Model Number: HD-CB-PC1
• Catalog Number: HD-CB-PC1
• 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	00609271000407 [Primary]
GS1	10609271000404 [Package]; Contains: 00609271000407; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271000401 [Package]; Contains: 00609271000407; 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 Polycast Cast Boot]

• 20609271000456: Extra-large Black
• 10609271000442: Large Black
• 10609271000435: Medium Black
• 20609271000425: Small Black
• 20609271000418: Extra-small Black
• 20609271000401: Pediatric Black