BELRAY II AR-97WKCNJ3

GUDID 04952195093922

097 X-RAY WK with 12"Arm

TAKARA-BELMONT CO., LTD.

Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue
Primary Device ID04952195093922
NIH Device Record Key5e9f7805-b617-412f-b346-bb588414dbbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBELRAY II
Version Model Number097
Catalog NumberAR-97WKCNJ3
Company DUNS690540349
Company NameTAKARA-BELMONT 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

Customer Support Contacts

Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp
Phone+810662135945
Emaile-nishizawa@belmont.jp

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104952195093922 [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 Date2016-09-21

On-Brand Devices [BELRAY II]

04952195093939097 X-RAY WK with 40"Arm
04952195093922097 X-RAY WK with 12"Arm
04952195093915097 X-RAY WK with 20"Arm
04952195093908097 X-RAY WK with 26"Arm
04952195093809097 X-RAY WK with 31"Arm

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