EPS Plating System

Basic Information

• Brand Name: EPS Plating System
• Primary DI: B471712400010
• Version / Model: 71240001
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC
• Labeler DUNS: 080068420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-23
• Public Version: 1
• Public Version Date: 2020-11-02
• Public Version Status: New
• Public Device Record Key: f3e78104-a79d-4192-a921-778aa523d1e2

Device Description

Plate Bender (2) Pack 1.5mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
61211	Manual orthopaedic bender, single-use	A sterile, manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B471712400010	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius