GUDID 00840682118101

USA INSTRUMENTS, INC.

MRI system coil, radio-frequency
Primary Device ID00840682118101
NIH Device Record Key06de4cc4-56ca-498a-8004-7d1ff348b88e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSigna HD 1.5T 8-CH Body Array Coil
Company DUNS804517571
Company NameUSA INSTRUMENTS, INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682118101 [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 Date2016-08-01

Devices Manufactured by USA INSTRUMENTS, INC.

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00195278575814 - NA2023-07-05 3.0T 16ch AIR AA
00840682108867 - NA2020-03-05
00840682114387 - NA2020-03-05
00840682114394 - NA2020-03-05
00840682114400 - NA2020-03-05
00840682114547 - NA2020-03-05
00840682115780 - NA2020-03-05

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