GEHC 1.5T Pediatric Head and Spine Array

GUDID 00859193006012

SCANMED, LLC

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency
Primary Device ID00859193006012
NIH Device Record Key10e65631-1dd7-40cb-96c3-653c9e4a5ea1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEHC 1.5T Pediatric Head and Spine Array
Version Model NumberE8800DA
Company DUNS080151631
Company NameSCANMED, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859193006012 [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 Date2017-01-12

Devices Manufactured by SCANMED, LLC

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00859193006593 - ScanMed Elbow Coil2021-04-20
00859193006579 - ScanMed Orbit and Mandible Coil2020-03-05
00859193006005 - ScanMed PROCURE™ Coil2020-03-05
00859193006012 - GEHC 1.5T Pediatric Head and Spine Array2020-03-05
00859193006012 - GEHC 1.5T Pediatric Head and Spine Array2020-03-05
00859193006029 - GEHC 1.5T Adult Head and Spine Array2020-03-05
00859193006036 - ScanMed Knee/Foot Coil2020-03-05
00859193006043 - ScanMed Knee/Foot Coil2020-03-05

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