BRAVO 17V Autoclave - Table-top steam sterilizer (Loaner) - Scican Ltd

Duns Number:204137145

Device Description: Table-top steam sterilizer (Loaner)

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More Product Details

Catalog Number

M7A310014-L

Brand Name

BRAVO 17V Autoclave

Version/Model Number

M7A310014-L

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

K090265

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

358f3900-cc0c-4524-8d69-1e707610d8da

Public Version Date

September 11, 2019

Public Version Number

1

DI Record Publish Date

September 03, 2019

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