EH

Basic Information

• Brand Name: EH
• Primary DI: 00816795020686
• Version / Model: 0.3ozt
• Company Name: AURIDENT INC
• Labeler DUNS: 030580955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8ad910d3-48a9-4a31-9e25-af485bb8a464

Device Description

Dental alloy restorations

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: 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
EJT	Alloy, Gold-Based Noble Metal	Dental	872.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36998	In-exsufflator	A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816795020686	GS1