HC150 - 1.5T Head Coil Lower Neuro II-S

GUDID 00857534006523

LOWER COIL ASSEMBLY, 1.5T Neuro II-S, 119980-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency
Primary Device ID00857534006523
NIH Device Record Key1ee49784-2e2f-46bd-9677-5251159a9f7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHC150 - 1.5T Head Coil Lower Neuro II-S
Version Model NumberHC150 Lower Coil
Company DUNS079990922
Company NameDEERFIELD IMAGING, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100857534006523 [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 Number3
Public Version Date2020-03-05
Device Publish Date2018-03-05

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