Philips - SENSE FLEX M 3.0T ODU - Shanghai Chenguang Medical Technologies Co., Ltd

Duns Number:545297822

Device Description: SENSE FLEX M 3.0T ODU

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More Product Details

Catalog Number

-

Brand Name

Philips

Version/Model Number

4522-133-17211

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

-

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

70c53c1d-5031-4554-858d-53791e2cd168

Public Version Date

October 11, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES 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. 50