Atlas SPEEDER Spine Coil

GUDID 00814848020201

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency
Primary Device ID00814848020201
NIH Device Record Keyc93a66b6-562c-4d50-973e-fc372996027c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtlas SPEEDER Spine Coil
Version Model NumberQ7000035
Company DUNS614760119
Company NameQUALITY ELECTRODYNAMICS LLC
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
GS100814848020201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-09-06

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

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00814848020508 - Shape Coil2021-08-30
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00814848020515 - 2Tx 28Rx Knee Coil2021-02-22
00814848020423 - Contour 242020-03-05
00814848020003 - 18ch T/R Knee Coil2020-03-05
00814848020010 - Atlas SPEEDER Head/Neck Coil2020-03-05
00814848020027 - Wrist SPEEDER Coil2020-03-05

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