MN-111 - TABLE-TOP STEAM STERILIZER MN-111 200-240V TP316 - W & H STERILIZATION SRL

Duns Number:429111904

Device Description: TABLE-TOP STEAM STERILIZER MN-111 200-240V TP316

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More Product Details

Catalog Number

19943101

Brand Name

MN-111

Version/Model Number

MN-111

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172825

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

5a2e7ac6-a5bf-4c5a-810a-c9fb738e770b

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"W & H STERILIZATION SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14