OrthoFX Home Impression Kit

Basic Information

• Brand Name: OrthoFX Home Impression Kit
• Primary DI: 00860003321744
• Version / Model: HIK1-rev
• Company Name: ORTHOFX
• Labeler DUNS: 033755180
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 1
• Public Version Date: 2020-12-02
• Public Version Status: New
• Public Device Record Key: 79f3d880-326a-4740-8ce9-c65a17f25444

Device Description

Revise Home Impression Kit UDI (PVS version)

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	Material, Impression	Dental	872.3660	2
EHY	Tray, Impression, Preformed	Dental	872.6880	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48085	Dental impression material kit, single-use	A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003321744	GS1

Customer Contacts

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