Duns Number:204137145
Device Description: Removable sterilization chamber (Extended length) for the Statim 5000 G4 Cassette Autocla Removable sterilization chamber (Extended length) for the Statim 5000 G4 Cassette Autoclave
Catalog Number
01-112509S
Brand Name
Cassette Complete (5000 Ext G4)
Version/Model Number
01-112509S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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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
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
0c64aa29-e183-4c87-8eac-59ac13766879
Public Version Date
December 18, 2018
Public Version Number
4
DI Record Publish Date
August 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |