Nx Nail Sizing Template

Basic Information

• Brand Name: Nx Nail Sizing Template
• Primary DI: 00857676008423
• Version / Model: 961
• Catalog Number: 961
• Company Name: Eca Medical Instruments
• Labeler DUNS: 084330422
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-26
• Public Version: 1
• Public Version Date: 2023-08-03
• Public Version Status: New
• Public Device Record Key: 450174b0-12b0-454e-91d6-2b2e8037456e

Device Description

Nx Nail Sizing Template

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
HWT	Template	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64122	Surgical screwdriver trial	A hand-held tool intended to be used to determine the correct size of surgical screwdriver or screwdriver insert required to insert or remove an implantable bone screw. It consists of a set of polymer rods with distal ends in graduated sizes to fit into one of the variations of screw head (e.g., Hex, square, cross-head). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857676008423	GS1