Duns Number:813116209
Device Description: The Amsco Eagle EO Sterilizer, Tabletop 100% ethylene oxide (EO) gas sterilizer/aerator pr The Amsco Eagle EO Sterilizer, Tabletop 100% ethylene oxide (EO) gas sterilizer/aerator provides effective low-temperature sterilization of heat-sensitive items.
Catalog Number
FF85
Brand Name
Amsco Eagle
Version/Model Number
3017
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 09, 2020
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
K931872
Product Code
FLF
Product Code Name
Sterilizer, ethylene-oxide gas
Public Device Record Key
25dddb8f-a00c-41ad-bfbb-13279fbebe95
Public Version Date
October 09, 2020
Public Version Number
6
DI Record Publish Date
September 14, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |