Phosphor Storage Plate

Basic Information

• Brand Name: Phosphor Storage Plate
• Primary DI: D678735786F0
• Version / Model: 73578-6F
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-16
• Public Version: 1
• Public Version Date: 2022-12-26
• Public Version Status: New
• Public Device Record Key: d95fa38a-dbce-4d64-a998-57dfd1c68d1f

Device Description

The reusable phosphor storage plates are used to store intraoral or extraoral X-ray images in dental applications. Intraoral phosphor storage plates must be used in combination with Air Techniques barrier envelopes.

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
IWZ	Film, Radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45256	Digital imaging cassette/storage phosphor screen, dental	A combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D678735786F1	HIBCC	Box	1	In Commercial Distribution
Primary	D678735786F0	HIBCC

Customer Contacts

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