ScanMed Knee/Foot Coil

GUDID 00859193006081

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 ID00859193006081
NIH Device Record Key4e8d8191-d648-4d1a-b31f-b1bf4f18a9d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanMed Knee/Foot Coil
Version Model Number116GE3001
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
GS100859193006081 [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 Knee/Foot Coil]

00859193006104116SI3001
00859193006098116SI1501
00859193006081116GE3001
00859193006074116GE1501
00859193006067108SI3001
00859193006050108SI1501
00859193006043108GE3001
00859193006036108GE1501

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