Body Armor® PFA Walker BAPFA4

GUDID 14251853902840

Foot Stump Orthosis, Gray-Blue, XL

Darco (Europe) GmbH

Inflatable extremity splint

• Primary Device ID: 14251853902840
• NIH Device Record Key: 22a6ed99-7cb6-4c4c-9b54-3f27475508e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Armor® PFA Walker
• Version Model Number: BAPFA4
• Catalog Number: BAPFA4
• Company DUNS: 343551081
• Company Name: Darco (Europe) GmbH
• 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: false
• 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	04251853902843 [Primary]
GS1	14251853902840 [Package]; Contains: 04251853902843; Package: Box [4 Units]; In Commercial Distribution
GS1	24251853902847 [Package]; Contains: 04251853902843; 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: 2025-04-23
• Device Publish Date: 2025-04-15

Devices Manufactured by Darco (Europe) GmbH

• 20609271000357 - KERRAPED PLUS™ All Purpose Boot: 2025-06-30 S Black Round-toe
• 10609271000367 - KERRAPED PLUS™ All Purpose Boot: 2025-06-30 M Black Round-toe
• 10609271000374 - KERRAPED PLUS™ All Purpose Boot: 2025-06-30 L Black Round-toe
• 10609271000381 - KERRAPED PLUS™ All Purpose Boot: 2025-06-30 XL Black Round-toe
• 14251853902826 - Body Armor® PFA Walker: 2025-04-23 Foot Stump Orthosis, Gray-Blue, M
• 14251853902833 - Body Armor® PFA Walker: 2025-04-23 Foot Stump Orthosis, Gray-Blue, L
• 14251853902840 - Body Armor® PFA Walker: 2025-04-23Foot Stump Orthosis, Gray-Blue, XL
• 14251853902840 - Body Armor® PFA Walker: 2025-04-23 Foot Stump Orthosis, Gray-Blue, XL
• 24251853902854 - Body Armor® PFA Walker Liner: 2025-04-23 Liner, Gray, M