RFT - 1.5T 8ch Flex 50 Array (A-port) - Shenzhen RF Tech Co., Ltd.

Duns Number:530798780

Device Description: 1.5T 8ch Flex 50 Array (A-port)

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More Product Details

Catalog Number

M7006PC

Brand Name

RFT

Version/Model Number

10-F24261

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172222,K172222

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

06a0df76-beef-4574-89f9-28c5b3e3345c

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

December 13, 2017

Additional Identifiers

Package DI Number

16938146600048

Quantity per Package

1

Contains DI Package

06938146600041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SHENZHEN RF TECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6