KERRAPED™ All Purpose Boot KP2B

GUDID 10609271000268

M Black Round-toe

DARCO INTERNATIONAL, INC.

Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized Orthotic shoe, non-customized

• Primary Device ID: 10609271000268
• NIH Device Record Key: ad167d92-8edc-4011-ab0f-2e0d09a2eda9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KERRAPED™ All Purpose Boot
• Version Model Number: KP2B
• Catalog Number: KP2B
• 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: true
• 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	00609271000261 [Primary]
GS1	10609271000268 [Package]; Contains: 00609271000261; Package: Box [12 Units]; In Commercial Distribution
GS1	20609271000265 [Package]; Contains: 00609271000261; 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: 2023-02-16
• Device Publish Date: 2023-02-08

On-Brand Devices [KERRAPED™ All Purpose Boot]

• 20609271000289: XL Black Round-toe
• 20609271000272: L Black Round-toe
• 10609271000268: M Black Round-toe
• 10609271000251: S Black Round-toe