Imaging Plate

Basic Information

• Brand Name: Imaging Plate
• Primary DI: 40889978610095
• Version / Model: Imaging Plate
• Catalog Number: 8610099
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5e97c330-2a21-491a-8a35-5b2a9e6e90cf

Device Description

(2) SZ 3 DENTAL CR I/O IMAG PLATES

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: 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
EAM	Screen, intensifying, radiographic	Radiology	892.1960	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	60889978610099	GS1	Case	40	In Commercial Distribution
Primary	40889978610095	GS1
Unit of Use	00889978610097	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius