Primo Freeze

Basic Information

• Brand Name: Primo Freeze
• Primary DI: 00817744022720
• Version / Model: RE100SP
• Company Name: ECOTEC MANUFACTURING, INC.
• Labeler DUNS: 121411859
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-02
• Public Version: 2
• Public Version Date: 2024-11-15
• Public Version Status: Update
• Public Device Record Key: a4024e30-046c-4120-b708-df2e67b0e3c9
• Distribution End Date: 2024-11-14

Device Description

Endo Freeze Spray

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EAT	Tester, Pulp	Dental	872.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38787	Cryogenic spray, dental	A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. 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	00817744022720	GS1

Customer Contacts

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