X-CEL X-RAY CORPORATION

GUDID B216HDR715A401

TABLE TOP X-RAY MACHINE, 15mA, 50-70kV

ARQUILLA, INC.

Stationary basic diagnostic x-ray system, analogue
Primary Device IDB216HDR715A401
NIH Device Record Key75fd4411-c219-40da-9806-bc4cf386af4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-CEL X-RAY CORPORATION
Version Model NumberHDR-715A-40
Company DUNS062469945
Company NameARQUILLA, INC.
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

Customer Support Contacts

Phone8154552470
Emailguido@xcelxray.com
Phone8154552470
Emailguido@xcelxray.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB216HDR715A401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

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 Date2016-08-15

On-Brand Devices [X-CEL X-RAY CORPORATION]

B216MB715NT1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216LB715NT1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216HF718BD1PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
B216HDRI715A401TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
B216HDR715A401TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
B216FB910A40K1PODIATRY X-RAY MACHINE, 10mA, 50-90kV
B216FB715NT1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216BDXC7001PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216715TBD1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216715SD1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216715RSD1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216715BBD1PODIATRY X-RAY MACHINE, 15mA, 50-70kV
B216P700MAC1PODIATRY X-RAY MACHINE, 15mA, 50-70kV

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