KNEE COIL N. 2 SERV - Coil for S-scan - ESAOTE SPA

Duns Number:437384304

Device Description: Coil for S-scan

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More Product Details

Catalog Number

-

Brand Name

KNEE COIL N. 2 SERV

Version/Model Number

9101824201

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"

Yes

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

215a6b3e-7699-49e7-b25a-20059c4f5713

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESAOTE SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 161