PREVA, 76" REACH, GRAY, 12" CONE

Basic Information

• Brand Name: PREVA, 76" REACH, GRAY, 12" CONE
• Primary DI: 00841709103896
• Version / Model: DPD7-G1P
• Catalog Number: DPD7-G1P
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4f288bca-0659-461d-957d-3c73b0d15a3c

Device Description

Intraoral X-ray

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
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40960	Dental x-ray system collimator	A beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709103896	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112380	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