INTRASKAN DC 9992720200

GUDID D83399927202000

INTRASKAN DC WITH 33" EXTENSION ARM

ImageWorks

Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital
Primary Device IDD83399927202000
NIH Device Record Keya5fe6e30-edb6-4867-93e2-81104ea92630
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRASKAN DC
Version Model Number9992720200
Catalog Number9992720200
Company DUNS833648087
Company NameImageWorks
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD83399927202000 [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 Date2017-08-15

On-Brand Devices [INTRASKAN DC]

D83399927203000INTRASKAN DC FLOOR MOUNT
D83399927202000INTRASKAN DC WITH 33" EXTENSION ARM
D83399927201000INTRASKAN DC WITH 24" EXTENSION ARM
D83399927200000INTRASKAN DC WITH 15" EXTENSION ARM

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