Astek

Basic Information

• Brand Name: Astek
• Primary DI: 00840326421864
• Version / Model: 23011ASTEK3KIT
• Catalog Number: 23011ASTEK3KIT
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 47d2fecc-d8d6-47a7-b371-db3fb7b2e3d8

Device Description

inSafe Syringe, 2.2ml, Standard Non?Asp., T Type 3 Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
45152	Dental anaesthesia injection kit	A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20840326421868	GS1	Case	1	In Commercial Distribution
Primary	00840326421864	GS1
Package	10840326421861	GS1	Package	1	In Commercial Distribution

Customer Contacts

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