Plate Bender, 3 point

Basic Information

• Brand Name: Plate Bender, 3 point
• Primary DI: 00851599007198
• Version / Model: 215.010.25
• Company Name: JACE MEDICAL, LLC
• Labeler DUNS: 063554875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-26
• Public Version: 3
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: c786480f-04e3-4e79-affa-16d22257bd60
• Distribution End Date: 2022-12-31

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXP	Instrument, Bending Or Contouring	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47637	Bone fixation plate pliers	A manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851599007198	GS1