the Wand STA Handpiece

Basic Information

• Brand Name: the Wand STA Handpiece
• Primary DI: 20618874000046
• Version / Model: STA-5050-301
• Company Name: Milestone Scientific Inc.
• Labeler DUNS: 006891188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 600
• Record Status: Published
• Publish Date: 2018-01-26
• Public Version: 5
• Public Version Date: 2022-12-21
• Public Version Status: Update
• Public Device Record Key: 62da798c-dc76-4f59-bdf3-5d76a80f28a1

Device Description

STA Handpiece with needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EJI	Syringe, Cartridge	Dental	872.6770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60601	Dental computer assisted anaesthesia injection handpiece	A sterile, hand-held component of a dental computer assisted local anaesthesia delivery system intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically designed in the form of a pen or wand connected to a dental computer assisted anaesthesia injection unit via tubing, and used in conjunction with a dental anaesthesia cartridge and a needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20618874000046	GS1
Unit of Use	00618874603014	GS1

Premarket Submissions

Submission Number	Supplement Number
K061904	000