ScanMed Elbow Coil

GUDID 00859193006319

SCANMED, LLC

MRI system coil, radio-frequency
Primary Device ID00859193006319
NIH Device Record Key90091e46-6de2-43f9-bc12-408b4e419ef1
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanMed Elbow Coil
Version Model Number308SI3001
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
GS100859193006319 [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 Elbow Coil]

00859193006340316GE1501
00859193006319308SI3001
00859193006302308SI1501
00859193006296308GE3001
00859193006289308GE1501
00859193006593308GE1500

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