Prone Tool Set - Prone Tool Set for Mouldroom, including prone - MACROMEDICS B.V.

Duns Number:489730120

Device Description: Prone Tool Set for Mouldroom, including prone tool, reference tool and 5 cushions for head Prone Tool Set for Mouldroom, including prone tool, reference tool and 5 cushions for head positioning

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More Product Details

Catalog Number

112650

Brand Name

Prone Tool Set

Version/Model Number

DSPS-PTSET

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K142420

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

a4f44802-7380-4ddc-a61c-e0e81b6c1d19

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MACROMEDICS 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. 114