Wooden Applicators

Basic Information

• Brand Name: Wooden Applicators
• Primary DI: D798WA0
• Version / Model: WA
• Catalog Number: WA
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-25
• Public Version: 4
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: 2a0be3b2-cbe0-4359-9edb-4585f38c9476
• Distribution End Date: 2018-12-05

Device Description

Wooden Applicators are used to apply adhesive paste to any bracket or band surface.

Device Characteristics

• Single Use: Yes
• 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: No
• 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
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798WA0	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambiet conditions.