Patient Orient Dev - Pre-op

Basic Information

• Brand Name: Patient Orient Dev - Pre-op
• Primary DI: 09421028116046
• Version / Model: 900020106
• Catalog Number: 900020106
• Company Name: ENZTEC LIMITED
• Labeler DUNS: 592616445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 1
• Public Version Date: 2022-06-23
• Public Version Status: New
• Public Device Record Key: 6f1746b9-8049-4c5c-ba6e-1c5b04748c7f

Device Description

A non-invasive reusable instrument intended to be used to support an orthopaedic surgical procedure

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWT	Template	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44803	Orthopaedic spirit level	A hand-held surgical instrument intended to be used to establish a horizontal line or plane relative to the site of interest by means of an air bubble enclosed in a slightly-curved glass tube. When the bubble is aligned within the established settings (e.g., a centre circle, two lines) the horizontal has been established. The device is utilized to ensure that an orthopaedic device and/or instrument is in the centre of a specific plane (i.e., lateral, cephalad, caudal). The device may include a mechanism to mark the established centre point. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421028116046	GS1