ESPIRE

Basic Information

• Brand Name: ESPIRE
• Primary DI: 05056394328263
• Version / Model: Espire Elbow Pro- Left- White- Standard- COAPT
• Catalog Number: EEP-LWD-CO
• Company Name: HUGH STEEPER LIMITED
• Labeler DUNS: 210280350
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 400b2763-870a-4ae9-8db8-a18ea1a432c7

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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
IRE	Joint, Elbow, External Limb Component, Powered	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41099	Electrical elbow prosthesis	An artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. The control of the device is achieved by an electromechanical switch for the motor that is operated by body movement using straps or cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056394328263	GS1

Premarket Submissions

Submission Number	Supplement Number
K182757	000