Removal Tool, 3.5mm

Basic Information

• Brand Name: Removal Tool, 3.5mm
• Primary DI: 00840118118378
• Version / Model: EZO 135
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• Labeler DUNS: 078790947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 1
• Public Version Date: 2022-01-24
• Public Version Status: New
• Public Device Record Key: fe6029db-22d7-4561-99eb-401f40828f46

Device Description

Orthopaedic implant reamer

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65880	Orthopaedic implant reamer	A surgical tool designed to over-drill a cylindrical orthopaedic implant (screw, pin, intrameduallry nail) to facilitate its removal by excising overgrown bone or other tissue. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match the different sizes of implant. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840118118378	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	200	Millimeter
Outer Diameter	3.5	Millimeter