NA

Basic Information

• Brand Name: NA
• Primary DI: ETDG1827612
• Version / Model: 30G 0.3 x 13 mm, short, RW (regular wall), hub dark blue and front cap blue
• Company Name: medmix Deutschland GmbH
• Labeler DUNS: 314320603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-12-09
• Public Version: 1
• Public Version Date: 2022-12-19
• Public Version Status: New
• Public Device Record Key: ef13cd4f-21b1-45dc-a78b-2a6cd3bb5201

Device Description

Sterile Single-Use Dental Injection Needles are sterile, disposable, sharp bevel-edged, hollow tubular metal instruments with an integrated hub. Sterile Single-Use Dental Injection Needles should be used in combination with dental cartridge syringes (according to ISO 9997) in which a dental cylinder ampoule according to ISO 11040-1 is inserted.

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: Yes
• 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
DZM	Needle, Dental	Dental	872.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12740	Dental syringe needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	ETDG1827614	HIBCC		50	In Commercial Distribution
Primary	ETDG1827612	HIBCC
Unit of Use	ETDG182761	HIBCC