Midmark PREVA IntraOral Dental X-ray System P7015/H

GUDID 00841709103964

Intraoral X-ray

MIDMARK CORPORATION

Stationary intraoral dental x-ray system, digital
Primary Device ID00841709103964
NIH Device Record Key13e2673c-58bc-4d88-bbd2-2c2a9f5eb079
Commercial Distribution StatusIn Commercial Distribution
Brand NameMidmark PREVA IntraOral Dental X-ray System
Version Model NumberP7015/H
Catalog NumberP7015/H
Company DUNS005036025
Company NameMIDMARK CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-643-6275
Emailimagingtechsupport@midmark.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -35 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -35 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -35 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841709103964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Midmark PREVA IntraOral Dental X-ray System]

00841709104022Intraoral X-ray
00841709104015Intraoral X-ray
00841709104008Intraoral X-ray
00841709103995Intraoral X-ray
00841709103988Intraoral X-ray
00841709103971Intraoral X-ray
00841709103964Intraoral X-ray
00841709103957Intraoral X-ray
00841709102738Beam Limiting Device, 60mm, White
00841709102721Beam Limiting Device, 30 x 40mm, White
00841709102714Beam Limiting Device, 20 x 30mm, White
00841709102707Beam Limiting Device, 60mm, Long, White
00841709102691Beam Limiting Device, 35 x 45mm, Long, White
00841709102684Beam Limiting Device, 35 x 45mm, White
00841709102677Modular BLD Base Assy
00841709102660Intraoral X-ray MODULAR BLD, 60 mm CONE, LONG, GRAY
00841709102653Intraoral X-ray MODULAR BLD, 60 mm Cone, Gray
00841709102646Intraoral X-ray MODULAR BLD, 70 MM CONE
00841709102639Intraoral X-ray MODULAR BLD, 70MM CONE,  LONG (30CM)
00841709102622Intraoral X-ray MODULAR BLD, 35x45MM CONE  GRAY
00841709102615Intraoral X-ray MODULAR BLD, 35x45MM CONE LONG GRAY
00841709102608Intraoral X-ray MODULAR BLD, 30X40MM CONE,  LONG (30CM)
00841709102523Intraoral X-ray Preva Tube Head With Oil
00841709102516Intraoral X-ray Preva Mobile System
00841709102509Intraoral X-ray Preva System
00841709102493Intraoral X-ray
00841709102486Intraoral X-ray
00841709102479Intraoral X-ray
00841709102462Intraoral X-ray
00841709102455Intraoral X-ray
00841709102448Intraoral X-ray
00841709102431Intraoral X-ray
00841709102424Intraoral X-ray
00841709102417Intraoral X-ray
00841709102400Intraoral X-ray
00841709102394Intraoral X-ray
00841709102387Intraoral X-ray
00841709102370Intraoral X-ray
00841709102363Intraoral X-ray
00841709102356Intraoral X-ray
00841709102349Intraoral X-ray
00841709102332Intraoral X-ray
00841709102325Intraoral X-ray
00841709102318Intraoral X-ray
00841709102301Intraoral X-ray
00841709102295Intraoral X-ray
00841709102288Intraoral X-ray
00841709102271Intraoral X-ray
00841709102264Intraoral X-ray
00841709102257Intraoral X-ray
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