COIL N.3 (UPPER LIMB)

GUDID 08056304453181

Coil for C-scan

ESAOTE SPA

MRI system coil, radio-frequency
Primary Device ID08056304453181
NIH Device Record Key8253a207-6502-42c6-8369-54f0515ab8c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOIL N.3 (UPPER LIMB)
Version Model Number9101584000
Company DUNS437384304
Company NameESAOTE SPA
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304453181 [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 Date2016-10-07

Devices Manufactured by ESAOTE SPA

08056304454287 - PX 1-52023-12-22
08056304454614 - 2CWS-L2023-12-22
08056304454621 - 5CWS-L2023-12-22
08056304454812 - TE 3-82023-12-22
08056304454836 - CX 1-82023-12-22
08056304454935 - LMX 4-202023-12-22
08056304454980 - MyLabX902023-12-22
08056304455000 - LX 3-152023-12-22

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