restor3d Disposable Trial Kit

Basic Information

• Brand Name: restor3d Disposable Trial Kit
• Primary DI: 00840097508702
• Version / Model: 4100-0101
• Company Name: Restor3d, Inc.
• Labeler DUNS: 080819836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-18
• Public Version: 3
• Public Version Date: 2023-11-02
• Public Version Status: Update
• Public Device Record Key: 5d55d5f1-298c-47dc-8171-495b0e41d99e
• Distribution End Date: 2023-05-01

Device Description

Cotton Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
61246	Surgical implant/trial-implant/sizer holder, single-use	A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840097508702	GS1