Data Logger Statim/Hydrim - Data logger for Statim Cassette Autoclaves and - Scican Ltd

Duns Number:204137145

Device Description: Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers

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More Product Details

Catalog Number

01-111770

Brand Name

Data Logger Statim/Hydrim

Version/Model Number

01-111770

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

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

8b9007bf-9b77-4cc9-95d7-9ad97140391c

Public Version Date

February 23, 2022

Public Version Number

1

DI Record Publish Date

February 15, 2022

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