Hu-Friedy MFG Co., LLC.

Basic Information

• Brand Name: Hu-Friedy MFG Co., LLC.
• Primary DI: 10889950075217
• Version / Model: UERTWSO
• Company Name: HU-FRIEDY MFG. CO., LLC
• Labeler DUNS: 005085972
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-19
• Public Version: 1
• Public Version Date: 2023-07-27
• Public Version Status: New
• Public Device Record Key: b52ad1a4-ddcf-4a35-b63f-79012dcff448

Device Description

Piezo Short Guardian Wrench E-Series Ora

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47675	Ultrasonic surgical system torque wrench, reusable	A hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889950075217	GS1

Customer Contacts

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