Midmark PREVA IntraOral Dental X-ray System

Basic Information

• Brand Name: Midmark PREVA IntraOral Dental X-ray System
• Primary DI: 00841709102523
• Version / Model: 30-A1027
• Catalog Number: 30-A1027
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 024ded36-9b29-4f75-8ebd-d6cfc459ec8a

Device Description

Intraoral X-ray Preva Tube Head With Oil

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EHD	Unit, X-Ray, Extraoral With Timer	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35618	X-ray tube housing assembly, diagnostic	A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709102523	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043092	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -35 – 66 Degrees Celsius