CryoProbe - H & O Equipments SA

Duns Number:370212933

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More Product Details

Catalog Number

S-HO-NOCX-12-S24-PR

Brand Name

CryoProbe

Version/Model Number

8g N2O cartridges

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K024009,K024009,K024009

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

37674279-5a38-4efb-9b57-3c9dab82521b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

B386SHONOCX12S24PR2

Quantity per Package

12

Contains DI Package

B386SHONOCX12S24PR1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"H & O EQUIPMENTS SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 31