PERFORMANCE HEALTH

Basic Information

• Brand Name: PERFORMANCE HEALTH
• Primary DI: 00840216112117
• Version / Model: A37132
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-09
• Public Version: 1
• Public Version Date: 2022-08-17
• Public Version Status: New
• Public Device Record Key: c7d7f57a-c94f-42ba-9a13-52ab6e463e63

Device Description

90° Wire Bender

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: 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
HXW	Bender	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33390	ENT wire bending die	A device designed for external conforming (i.e., bending) of wires during ear/nose/throat (ENT), otorhinolaryngology procedures. The device consists of a metallic solid base and appropriate attachments on its surface that permit bending of wires in appropriate angles (e.g., 90?, 45?); it typically includes a millimetric scale to improve the precision of the procedure. It is used to conform wires on a separate table or bench as they are needed, typically while performing endaural (ear) surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216112117	GS1