DUNLEE SENTINELLE - Lateral Array Coil Right VGTT - Philips Medical Systems Nederland B.V.

Duns Number:413819707

Device Description: Lateral Array Coil Right VGTT

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More Product Details

Catalog Number

-

Brand Name

DUNLEE SENTINELLE

Version/Model Number

300009325911

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

c1dea2ed-7f1d-4817-96a4-a02c6f8b4c44

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 349