DX-58 Paper Pak

Basic Information

• Brand Name: DX-58 Paper Pak
• Primary DI: H665180011
• Version / Model: 18001
• Catalog Number: 18001
• Company Name: Flow X Ray Corporation
• Labeler DUNS: 010016319
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 5
• Public Version Date: 2023-06-28
• Public Version Status: Update
• Public Device Record Key: 2bd24495-7ec0-4fa3-9fe8-1ff54bad5626
• Distribution End Date: 2023-06-21

Device Description

D speed Size 2 Intraoral Dental Film in paper packets. 150 films per box

Device Characteristics

• Single Use: Yes
• 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: 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
Primary	H665180011	HIBCC
Unit of Use	H665180010	HIBCC
Secondary	00812045030016	GS1