MAX-JECT DENTAL NEEDLES

Basic Information

• Brand Name: MAX-JECT DENTAL NEEDLES
• Primary DI: D89260705413541
• Version / Model: 6070541354
• Company Name: MAXILL, INC.
• Labeler DUNS: 079343581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-09-06
• Public Version: 1
• Public Version Date: 2022-09-14
• Public Version Status: New
• Public Device Record Key: 490e9051-d35f-43d7-87bb-199d3a61a5fc

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: 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
63097	Dental anaesthesia syringe/needle	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle; the needle may be attached or detached. The syringe is typically made of plastic and/or silicone materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D89260705413542	HIBCC	Case	5000	In Commercial Distribution
Primary	D89260705413541	HIBCC
Unit of Use	D89260705413540	HIBCC