PEDRA PEDRA-1417FG

GUDID 08800099500045

Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)

Radisen Co., Ltd.

Indirect flat panel x-ray detector
Primary Device ID08800099500045
NIH Device Record Key4fa7ea05-c6a1-4a6a-8bfc-9a35797193c2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEDRA
Version Model Number1417FG
Catalog NumberPEDRA-1417FG
Company DUNS694770428
Company NameRadisen Co., Ltd.
Device Count1
DM Exempttrue
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
GS108800099500045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-23
Device Publish Date2023-11-15

On-Brand Devices [PEDRA]

08800099500090Solid State X-ray Imager (Flat Panel / Digital Imager)
08800099500083Solid State X-ray Imager (Flat Panel / Digital Imager)
08800099500069Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500052Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500045Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500038Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500021Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500014Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
08800099500007Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)

Trademark Results [PEDRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDRA
PEDRA
90095456 not registered Live/Pending
Pedra Technology Pte. Ltd.
2020-08-05
PEDRA
PEDRA
78612447 3181873 Dead/Cancelled
Macway Uhl, LLC
2005-04-20

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