CyclaPlex Drill Guide

Basic Information

• Brand Name: CyclaPlex Drill Guide
• Primary DI: 07290017626192
• Version / Model: V7
• Catalog Number: DG-9201
• Company Name: ALPHAMET LTD
• Labeler DUNS: 600372473
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-12
• Public Version: 1
• Public Version Date: 2020-02-20
• Public Version Status: New
• Public Device Record Key: 8bfbc4d9-aaad-4abd-aa41-f35fe3ce857e

Device Description

The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61929	Orthopaedic implant aiming/guiding block attachment tool	A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017626192	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183094	000