Phosphor Storage Plate IDX S3

GUDID E247G36231

DÜRR DENTAL SE

Digital imaging storage phosphor screen
Primary Device IDE247G36231
NIH Device Record Key8eb28bdd-ebb2-4323-b92e-491814ab89ba
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhosphor Storage Plate IDX S3
Version Model NumberG3613
Company DUNS315563684
Company NameDÜRR DENTAL SE
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCE247G36130 [Primary]
HIBCCE247G36231 [Package]
Contains: E247G36130
Package: [2 Units]
In Commercial Distribution

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-19

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).

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.