PHOT-X IIs Model 505 AR-55WKCNJ5

GUDID 04952195248247

PHOT-X IIS 505 WK with 20"Arm

TAKARA-BELMONT CO., LTD.

Stationary intraoral dental x-ray system, analogue
Primary Device ID04952195248247
NIH Device Record Key5aa68f5b-4d01-4ce2-a793-4cf108289075
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHOT-X IIs Model 505
Version Model Number505
Catalog NumberAR-55WKCNJ5
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+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com
Phone+1(800)223-1192
Emailgstern@belmontequip.com

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
GS104952195248247 [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 Date2016-09-21

On-Brand Devices [PHOT-X IIs Model 505]

04952195280384PHOT-X IIS 505 WK with 26"Arm LCD Subcontroller
04952195278541PHOT-X IIS 505 WK with 12"Arm LCD Subcontroller
04952195278534PHOT-X IIS 505 WK with 40"Arm LCD Subcontroller
04952195277063PHOT-X IIS 505 WK with 20"Arm LCD Subcontroller
04952195277056PHOT-X IIS 505 WK with 31"Arm LCD Subcontroller
04952195250424PHOT-X IIS 505 WK with 40"Arm
04952195249213PHOT-X IIS 505 WK with 31"Arm
04952195248247PHOT-X IIS 505 WK with 20"Arm
04952195196258PHOT-X IIS 505 WK with 26"Arm
04952195142248PHOT-X IIS 505 WK with 12"Arm

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