Espire Elbow

Basic Information

• Brand Name: Espire Elbow
• Primary DI: 00841747180484
• Version / Model: EEP RSD
• Company Name: COLLEGE PARK INDUSTRIES, INC.
• Labeler DUNS: 623191137
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-16
• Public Version: 2
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 67240806-d074-4a6b-98b0-3b484356577f
• Distribution End Date: 2021-07-13

Device Description

Espire Elbow Pro, Right, Silver, Standard

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: Yes
• Has Lot/Batch Number: No
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41100	Myoelectric elbow prosthesis	A powered 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. Surface electrodes embedded in the device make contact with the skin and amplify muscle action potentials from voluntary contracting muscle in the residual limb/trunk, which turns on the motor to provide a function.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841747180484	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]