Wolf X-Ray

Basic Information

• Brand Name: Wolf X-Ray
• Primary DI: 00843696115012
• Version / Model: 10019
• Company Name: Flow X Ray Corporation
• Labeler DUNS: 010016319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 2
• Public Version Date: 2023-06-28
• Public Version Status: Update
• Public Device Record Key: 9bfec3ef-f558-475b-8b78-ebbc317c53d8

Device Description

Intensifying Screen, Hi Plus, 10" X 12"

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: 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
34317	X-ray intensifying screen	A device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843696115012	GS1