OSE

Basic Information

• Brand Name: OSE
• Primary DI: 00810042120013
• Version / Model: 0195-KEY
• Company Name: ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
• Labeler DUNS: 077801124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-13
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: d2867c9a-b532-4573-aff5-4fb4e5f7488d

Device Description

Palatal Swivel Key

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
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64768	Orthodontic palate expander screw key	A hand-held device designed to manually adjust an orthodontic palate expander (not included), by rotating the expander’s screw, to help create space for correct upper teeth alignment. It is comprised of a handle with an expander-engaging pin at the distal end which is inserted into the screw and rotated to adjust the width of the expander. This is a reusable device intended for single patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042120013	GS1