PREVA EXPORT MOBILE SYSTEM, DEUTSCH PE7017DM

GUDID 00841709103513

Intraoral X-ray, Mobile

MIDMARK CORPORATION

Mobile intraoral dental x-ray system, digital
Primary Device ID00841709103513
NIH Device Record Key4fc699b5-f4b9-483d-9fe6-e3bd751e7914
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVA EXPORT MOBILE SYSTEM, DEUTSCH
Version Model NumberPE7017DM
Catalog NumberPE7017DM
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

Phone1-800-634-6275
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
GS100841709103513 [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 Date2016-09-23

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