GUDID 00840682136655

USA INSTRUMENTS, INC.

MRI system coil, radio-frequency
Primary Device ID00840682136655
NIH Device Record Keycbcb31b1-24b4-45db-bbfc-84dfa1b39a57
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5999959
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
GS100840682136655 [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 Number2
Public Version Date2020-03-05
Device Publish Date2018-06-08

Devices Manufactured by USA INSTRUMENTS, INC.

00195278665249 - NA2023-08-11 48CH HEAD COIL - POSTERIOR
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.