Phosphor Storage Plate IDX S3

Basic Information

• Brand Name: Phosphor Storage Plate IDX S3
• Primary DI: E247G36130
• Version / Model: G3613
• Company Name: DÜRR DENTAL SE
• Labeler DUNS: 315563684
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-19
• Public Version: 1
• Public Version Date: 2021-09-27
• Public Version Status: New
• Public Device Record Key: 8eb28bdd-ebb2-4323-b92e-491814ab89ba

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: 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
IWZ	Film, Radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44826	Digital imaging storage phosphor screen	A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	E247G36231	HIBCC		2	In Commercial Distribution
Primary	E247G36130	HIBCC