ScanMed Blanket Coil

GUDID 00859193006173

SCANMED, LLC

MRI system coil, radio-frequency
Primary Device ID00859193006173
NIH Device Record Key3a9b809a-d715-4663-a1b6-adcc8a65e510
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanMed Blanket Coil
Version Model Number516SI1501
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
GS100859193006173 [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

On-Brand Devices [ScanMed Blanket Coil]

00859193006463516PH3001
00859193006180516SI3001
00859193006173516SI1501
00859193006166516GE3001
00859193006159516GE1501

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