Body Armor® PFA Walker Liner BAPFAL2

GUDID 24251853902854

Liner, Gray, M

Darco (Europe) GmbH

Inflatable extremity splint

• Primary Device ID: 24251853902854
• NIH Device Record Key: 372b9319-633a-4163-aae7-e7ec715ee5d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Armor® PFA Walker Liner
• Version Model Number: BAPFAL2
• Catalog Number: BAPFAL2
• 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: 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	04251853902850 [Primary]
GS1	24251853902854 [Package]; Contains: 04251853902850; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• FZF: Splint, Extremity, Inflatable, External

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

• 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: 2025-04-23 Foot Stump Orthosis, Gray-Blue, XL
• 24251853902854 - Body Armor® PFA Walker Liner: 2025-04-23Liner, Gray, M
• 24251853902854 - Body Armor® PFA Walker Liner: 2025-04-23 Liner, Gray, M
• 24251853902861 - Body Armor® PFA Walker Liner: 2025-04-23 Liner, Gray, L
• 04251853902874 - Body Armor® PFA Walker Liner: 2025-04-23 Liner, Gray, XL