HC150 - 1.5T Head Coil Lower

GUDID 00857534006134

LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency
Primary Device ID00857534006134
NIH Device Record Key5073364a-0bec-44cf-ab67-2f09bf1d9470
Commercial Distribution StatusIn Commercial Distribution
Brand NameHC150 - 1.5T Head Coil Lower
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
GS100857534006134 [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 Date2016-09-12

On-Brand Devices [HC150 - 1.5T Head Coil Lower]

00857534006448LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600
00857534006134LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000

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