ALGINELLE

Basic Information

• Brand Name: ALGINELLE
• Primary DI: 18016200010441
• Version / Model: KAL001
• Catalog Number: KAL102
• Company Name: LASCOD SPA
• Labeler DUNS: 436269609
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5e13fb43-9300-40f4-8c56-426b62bd5d25

Device Description

Orange alginate type 1 (450g) CATALOGUE NUMBER: - KAL102 = carton box containing n. 20 bags KAL001

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: 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	18016200010441	GS1
Package	18016200010151	GS1	carton box	20	In Commercial Distribution

Storage Conditions

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