hydrogum 5

Basic Information

• Brand Name: hydrogum 5
• Primary DI: EZHISP500511
• Version / Model: SP50051
• Catalog Number: SP50051
• Company Name: ZHERMACK SPA
• Labeler DUNS: 432971034
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2023-02-16
• Public Version Status: Update
• Public Device Record Key: 24ff214c-dab1-4fb5-878c-0536d754b80b
• Distribution End Date: 2022-12-30

Device Description

Alginate impression material

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EZHISP500511	HIBCC
Unit of Use	EZHISP500510	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	63	Gram
Device Size Text, specify			3x21 gr