Fiducial Coil with Arm Mount (Receive Only) - The Promaxo Fiducial Coil with Arm Mount is a - Promaxo, Inc.

Duns Number:103665187

Device Description: The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in c The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).

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More Product Details

Catalog Number

7181

Brand Name

Fiducial Coil with Arm Mount (Receive Only)

Version/Model Number

7181

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

c8ae5fc5-00d0-46c7-856f-3f357da8595c

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROMAXO, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8