Midmark Vantage Cephalometric Sensor 60-A1009

GUDID 00841709102554

Panoramic X-ray Cephalometric Extension Assembly

MIDMARK CORPORATION

Stationary cephalometric x-ray system, digital
Primary Device ID00841709102554
NIH Device Record Keyc45fd158-f4ce-4073-a7a9-3880f0076b8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMidmark Vantage Cephalometric Sensor
Version Model Number60-A1009
Catalog Number60-A1009
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
GS100841709102554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

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 Date2016-09-22

On-Brand Devices [Midmark Vantage Cephalometric Sensor]

00841709102585Panoramic X-ray Assembly with Cephalometric Extension with no sensor
00841709102554Panoramic X-ray Cephalometric Extension Assembly
00841709102547Panoramic X-ray CephalometricSensor Assembly

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