PREVA, 76" REACH, DEUTSCH W/TWO STUD MOUNT, WHITE PE7017-D2-W

GUDID 00841709103469

Intraoral X-ray with Two-stud Mount and Handswitch

MIDMARK CORPORATION

Stationary intraoral dental x-ray system, digital
Primary Device ID00841709103469
NIH Device Record Keydb6b0af3-351c-4c10-9ab6-cc04037defb5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVA, 76" REACH, DEUTSCH W/TWO STUD MOUNT, WHITE
Version Model NumberPE7017-D2-W
Catalog NumberPE7017-D2-W
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
GS100841709103469 [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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