DARCO® Body Armor® Night Splint

Basic Information

• Brand Name: DARCO® Body Armor® Night Splint
• Primary DI: 00609271899162
• Version / Model: BADS-S
• Catalog Number: BADS-S
• Company Name: DARCO INTERNATIONAL, INC.
• Labeler DUNS: 184231298
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 1
• Public Version Date: 2023-02-16
• Public Version Status: New
• Public Device Record Key: f7c4bca7-1f29-4a9d-943f-11179c4cbf25

Device Description

S Blue

Device Characteristics

• Single Use: Yes
• 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	A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, 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	20609271899166	GS1	Case	12	In Commercial Distribution
Primary	00609271899162	GS1
Package	10609271899169	GS1	Box	4	In Commercial Distribution