Expression MR FlexTEMP System, Jacket 989803178181

GUDID 00884838033238

INVIVO CORPORATION

Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover
Primary Device ID00884838033238
NIH Device Record Key50cd2c25-b0be-4ab5-92e9-41fa92de9a7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpression MR FlexTEMP System, Jacket
Version Model Number989803178181
Catalog Number989803178181
Company DUNS013649151
Company NameINVIVO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838033238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00884838033238]

Radiation Sterilization

[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

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[00884838033238]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-31
Device Publish Date2016-09-29

Devices Manufactured by INVIVO CORPORATION

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00884838115309 - Invivo2022-11-30 dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grids Upper dS Breast 16Ch I/T; 4 Medial Grids dS Breast 16CH I/T; MRI Needl
00884838115255 - Invivo2022-11-28 BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; M
00884838115507 - Sentinelle2022-10-24 DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinelle
00884838115514 - Sentinelle2022-10-24 DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinell
00884838105195 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Left
00884838105201 - Sentinelle2022-10-20 dS 3.0T 4CH Lateral Right
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