STATIM 5000 G4 Cassette Autoclave - Table-top steam sterilizer with removable - Scican Ltd

Duns Number:204137145

Device Description: Table-top steam sterilizer with removable cassette sterilization chamber

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More Product Details

Catalog Number

G4-201103

Brand Name

STATIM 5000 G4 Cassette Autoclave

Version/Model Number

G4-201103

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

549e0fd1-80ba-465c-ae1d-a6a4f2c755bd

Public Version Date

December 18, 2018

Public Version Number

4

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCICAN LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 114