Harvard TraySive

Basic Information

• Brand Name: Harvard TraySive
• Primary DI: EHAR70837531
• Version / Model: 7083753
• Company Name: Harvard Dental International GmbH
• Labeler DUNS: 341553293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 235f143f-a1b8-4793-bcf7-f288fe38750c

Device Description

Tray adhesive

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16658	Dental impression material adhesive	A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EHAR70837531	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius