Take 1 Advanced

Basic Information

• Brand Name: Take 1 Advanced
• Primary DI: 10841396102469
• Version / Model: 35190
• Company Name: KERR CORPORATION
• Labeler DUNS: 847905890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2020-03-16
• Public Version Status: Update
• Public Device Record Key: 49974e90-54b9-4ceb-8233-911016351b04

Device Description

Impression Material - Product Sample - Regular Body - Rigid Tray - Fast Set

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
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being 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	10841396102469	GS1
Unit of Use	00841396102462	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambient temperature