Skan C Mobile C - Arm X - Ray system

GUDID 08904269405519

SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.

SKANRAY TECHNOLOGIES LIMITED

Portable general-purpose fluoroscopic x-ray system, digital
Primary Device ID08904269405519
NIH Device Record Key76c05ccc-1d90-4e98-b4fb-b9b0b30b2542
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkan C Mobile C - Arm X - Ray system
Version Model NumberF303-000187-2
Company DUNS863358955
Company NameSKANRAY TECHNOLOGIES LIMITED
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108904269405519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-01-19
Device Publish Date2019-01-21

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08904269405519 - Skan C Mobile C - Arm X - Ray system2022-01-19SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.
08904269405519 - Skan C Mobile C - Arm X - Ray system2022-01-19 SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device ca

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