Dentus M2 Comfort

Basic Information

• Brand Name: Dentus M2 Comfort
• Primary DI: 05414904038802
• Version / Model: DENTUS M2 COMFORT 3x4cm
• Catalog Number: 34HLM
• Company Name: AGFA
• Labeler DUNS: 374444883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 1
• Public Version Date: 2022-11-24
• Public Version Status: New
• Public Device Record Key: c4f2c9f9-b432-470e-b4aa-29ceeb2e4111

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
40978	Dental x-ray film, non-screen	A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05414904231692	GS1		24	In Commercial Distribution
Primary	05414904038802	GS1
Unit of Use	05414904231685	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	3	Centimeter
Width	4	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.