Mistral-Air - Mistral-Air® Premium Paediatric - SYK - The Surgical Company International B.V.

Duns Number:409656493

Device Description: Mistral-Air® Premium Paediatric - SYK

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More Product Details

Catalog Number

-

Brand Name

Mistral-Air

Version/Model Number

MA3330-PM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

K101705,K101705

Product Code Details

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Device Record Status

Public Device Record Key

89757c4f-415f-4b44-bfcf-5bc65bdc3253

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

November 16, 2016

Additional Identifiers

Package DI Number

ET37MA3330PM1

Quantity per Package

40

Contains DI Package

ET37MA3330PM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"THE SURGICAL COMPANY INTERNATIONAL 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. 35