Prometheus Traction Splint

Basic Information

• Brand Name: Prometheus Traction Splint
• Primary DI: 05060483570051
• Version / Model: PDF101
• Catalog Number: PDF101
• Company Name: SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
• Labeler DUNS: 219545612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-01
• Public Version: 1
• Public Version Date: 2023-05-09
• Public Version Status: New
• Public Device Record Key: e84f7cd7-e6ab-42c3-8ae0-1c9b5769c367
• Distribution End Date: 2030-05-01

Device Description

The Prometheus Traction Splint is designed to be used on those patients with a suspected limb fracture.

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: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSP	Splint, Traction	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62041	First aid limb splint, non-mouldable, single-use	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060483570051	GS1