IMPRESSION JET

Basic Information

• Brand Name: IMPRESSION JET
• Primary DI: 04035873069591
• Version / Model: 2930000240
• Catalog Number: 2930000240
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-21
• Public Version: 1
• Public Version Date: 2021-11-29
• Public Version Status: New
• Public Device Record Key: 3fa390fa-dfad-43d9-bb6e-90a610e5c887

Device Description

IMPRESSION JET

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: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EID	Syringe, Restorative And Impression Material	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35969	Dental anaesthesia syringe, reusable	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 attached sterile needle; a needle is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035873069591	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: PROTECT FROM SUNLIGHT, KEEP DRY