PROIII 047

Basic Information

• Brand Name: PROIII 047
• Primary DI: 04952195359264
• Version / Model: AC-47R-FD36US
• Catalog Number: AC-47R-FD36US
• Company Name: TAKARA BELMONT CORP.
• Labeler DUNS: 690540349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-22
• Public Version: 2
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: ec96a81f-bd30-4982-b09f-6c8c22dd621f

Device Description

PROIII 047

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NRU	Chair, Dental, Without Operative Unit	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47144	Dental chair, electric	A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04952195359264	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit