Mixing tips blue 10:1

Basic Information

• Brand Name: Mixing tips blue 10:1
• Primary DI: EDET029551
• Version / Model: 02955
• Company Name: DETAX GmbH
• Labeler DUNS: 343947949
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-14
• Public Version: 2
• Public Version Date: 2022-11-08
• Public Version Status: Update
• Public Device Record Key: fc0402f4-2725-46f2-aac1-253c2eae2c2d

Device Characteristics

• Single Use: No
• 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: 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
EID	Syringe, Restorative And Impression Material	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35860	Dental impression material syringe, reusable	A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EDET029551	HIBCC