Cefla

Basic Information

• Brand Name: Cefla
• Primary DI: 08717228440441
• Version / Model: CEFPH5060
• Catalog Number: 97901717
• Company Name: DuPhaMed B.V.
• Labeler DUNS: 413491023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-23
• Public Version: 1
• Public Version Date: 2023-12-01
• Public Version Status: New
• Public Device Record Key: e8dce475-5761-4f56-8227-7ab9d54feec6

Device Description

Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior/periapical L - UDI 08717228440229 2x posterior/periapical R - UDI 08717228440236 50 x clip - UDI 08717228441790 1x positioning ring - UDI 8717228441028

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGZ	Holder, Film, X-Ray	Dental	872.1905	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717228440441	GS1