23Na 1Tx32Rx Head 7T

GUDID 04260487680164

23Na 1Tx32Rx Head 7T

RAPID Biomedical GmbH

MRI system coil, radio-frequency
Primary Device ID04260487680164
NIH Device Record Key3d48089b-bf3c-4d78-9308-2bc308a4c59c
Commercial Distribution StatusIn Commercial Distribution
Brand Name23Na 1Tx32Rx Head 7T
Version Model Number11371303
Company DUNS316037741
Company NameRAPID Biomedical GmbH
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104260487680164 [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 Number2
Public Version Date2020-03-05
Device Publish Date2019-08-23

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