1.5T BC-10 Transmit/Receive MRI Coil 42T9165

GUDID 20851607003017

Medspira 1.5T BC-10 Transmit/Receive MRI Coil

MEDSPIRA, LLC

MRI system coil, radio-frequency
Primary Device ID20851607003017
NIH Device Record Keyef2a3b26-14be-4076-bf53-4a1c8dec3877
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5T BC-10 Transmit/Receive MRI Coil
Version Model Number42T9165
Catalog Number42T9165
Company DUNS962187964
Company NameMEDSPIRA, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone612-789-0013
Emailinfo@medspira.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003013 [Primary]
GS110851607003010 [Package]
Contains: 00851607003013
Package: Box [1 Units]
In Commercial Distribution
GS120851607003017 [Package]
Contains: 10851607003010
Package: Shipper [1 Units]
In Commercial Distribution

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 Date2017-01-06

Devices Manufactured by MEDSPIRA, LLC

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10851607003348 - Single Patient Kit, mcompass, Anorectal Manometry 2-channel2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 2-channel
10851607003379 - Medspira Tablet PC with Power Supply2023-10-16 Medspira Tablet PC with Power Supply
10851607003393 - mcompass Anorectal Manometry System2023-10-16 mcompass Anorectal Manometry System
00851607003402 - Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack
10851607003416 - Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack
10851607003423 - Catheter, mcompass®, Biofeedback, 2-channel, 5-pack2023-10-16 Catheter, mcompass®, Biofeedback, 2-channel, 5-pack

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