HC300 -3T Head Coil Lower Assy

GUDID 00857534006424

Lower Assy, 3T IOH V2, 110840-600

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency
Primary Device ID00857534006424
NIH Device Record Keyc281c837-2f17-4161-8409-7126508f1bd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHC300 -3T Head Coil Lower Assy
Version Model NumberHC300 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
GS100857534006424 [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 Date2017-02-28

On-Brand Devices [HC300 -3T Head Coil Lower Assy]

00857534006424Lower Assy, 3T IOH V2, 110840-600
00857534006226Lower Assy, 3T IOH V2, 110840-000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.