ScanMed PROCURE™ Coil

GUDID 00859193006135

SCANMED, LLC

MRI system coil, radio-frequency
Primary Device ID00859193006135
NIH Device Record Keycedcb567-1e3e-4708-94ef-afb3aa23319c
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanMed PROCURE™ Coil
Version Model Number508SI1501
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
GS100859193006135 [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 PROCURE™ Coil]

00859193006456508PH3001
00859193006449508PH1501
00859193006425588PH3001
00859193006371588PH1501
00859193006210588SI1501
00859193006203588GE3001
00859193006197588GE1501
00859193006142508SI3001
00859193006135508SI1501
00859193006128508GE3001
00859193006111508GE1501
00859193006005588SI3001

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