Universal Needle Tips 18G (Pink) 100-Pack

Basic Information

• Brand Name: Universal Needle Tips 18G (Pink) 100-Pack
• Primary DI: 00359883003395
• Version / Model: 112118
• Catalog Number: 112118
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-12
• Public Version: 1
• Public Version Date: 2025-03-20
• Public Version Status: New
• Public Device Record Key: fe5aab25-2ebc-49b6-8776-1c4b8f1feab8

Device Description

Dental material injection cannula, single-use

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: Yes
• 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
JEW	TIP, RUBBER, ORAL HYGIENE	Dental	872.6650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60366	Dental material injection cannula, single-use	A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00359883003395	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature