Body Armor® PFA Walker

Basic Information

• Brand Name: Body Armor® PFA Walker
• Primary DI: 04251853902843
• Version / Model: BAPFA4
• Catalog Number: BAPFA4
• Company Name: Darco (Europe) GmbH
• Labeler DUNS: 343551081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-15
• Public Version: 2
• Public Version Date: 2025-09-24
• Public Version Status: Update
• Public Device Record Key: 22a6ed99-7cb6-4c4c-9b54-3f27475508e5

Device Description

Foot Stump Orthosis, Gray-Blue, XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32302	Inflatable extremity splint, reusable	A sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospital. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14251853902840	GS1	Box	4	In Commercial Distribution
Primary	04251853902843	GS1
Package	24251853902847	GS1	Case	12	In Commercial Distribution