Body Armor® PFA Walker BAPFA3

GUDID 14251853902833

Foot Stump Orthosis, Gray-Blue, L

Darco (Europe) GmbH

Inflatable extremity splint

• Primary Device ID: 14251853902833
• NIH Device Record Key: 8c70526e-9c9b-40b8-9f29-6f6ec585a658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Armor® PFA Walker
• Version Model Number: BAPFA3
• Catalog Number: BAPFA3
• 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	04251853902836 [Primary]
GS1	14251853902833 [Package]; Contains: 04251853902836; Package: Box [4 Units]; In Commercial Distribution
GS1	24251853902830 [Package]; Contains: 04251853902836; 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

On-Brand Devices [Body Armor® PFA Walker]

• 14251853902833: Foot Stump Orthosis, Gray-Blue, L
• 14251853902826: Foot Stump Orthosis, Gray-Blue, M