InSitu Coil 120019-000

GUDID 00857534006554

InSitu Coil, Open, 3T Large, 120019-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency
Primary Device ID00857534006554
NIH Device Record Keyb3ce52cd-1ebc-43e2-a181-9dd37fd62654
Commercial Distribution StatusIn Commercial Distribution
Brand NameInSitu Coil
Version Model NumberInSitu Coil, Open, 3T Large
Catalog Number120019-000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857534006554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-03-29

On-Brand Devices [InSitu Coil]

00857534006554InSitu Coil, Open, 3T Large, 120019-000
00857534006547InSitu Coil, Open, 1.5T Large 120018-000

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