ScanX Intraoral View

GUDID E247G86000

DÜRR DENTAL SE

Radiography digital imaging scanner
Primary Device IDE247G86000
NIH Device Record Keyb3fd5954-27fe-437e-82d0-a5447c25630c
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanX Intraoral View
Version Model NumberG8600
Company DUNS315563684
Company NameDÜRR DENTAL SE
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE247G86000 [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 Number2
Public Version Date2018-08-23
Device Publish Date2018-07-06

Devices Manufactured by DÜRR DENTAL SE

E24721301004130 - VistaPosition Anterior2024-05-27
E24721301004140 - VistaPosition Posterior2024-05-27
E24721301004150 - VistaPosition Endo2024-05-27
E24721301004160 - VistaPosition Bitewing2024-05-27
E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium2024-05-27
E247G38101 - VistaPosition Anterior/ Posterior Kit2024-05-27
E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 02023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 22023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).

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