Duns Number:813116209
Device Description: The AMSCO 400 60 Prevacuum Steam Sterilizer Single Door Right Hinge Recessed Steam is desi The AMSCO 400 60 Prevacuum Steam Sterilizer Single Door Right Hinge Recessed Steam is designed for sterilization of materials used in healthcare facilities.
Catalog Number
SR4421224011
Brand Name
AMSCO
Version/Model Number
AMSCO 400 Steam Sterilizer
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112055
Product Code
FLE
Product Code Name
Sterilizer, steam
Public Device Record Key
9a44ada6-8f77-4ac1-8a91-99a538bf72b7
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |