HYDRIM L110W G4 Instrument Washer - Automated instrument washer. Shorter height than - Scican Ltd

Duns Number:204137145

Device Description: Automated instrument washer. Shorter height than the original HYDRIM L110W-D01-G4 model.

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More Product Details

Catalog Number

L110W-D01SH-G4

Brand Name

HYDRIM L110W G4 Instrument Washer

Version/Model Number

L110W-D01SH-G4

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

LDS

Product Code Name

Device, Pasteurization, Hot Water

Device Record Status

Public Device Record Key

272ddbcb-0ac3-4342-9f7a-de89fe8ad034

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 07, 2018

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