Duns Number:813116209
Device Description: Extra Shelf for Loading Car (6STU, 39-Inch, 990MM) used with the AMSCO 600 Steam Sterilize Extra Shelf for Loading Car (6STU, 39-Inch, 990MM) used with the AMSCO 600 Steam Sterilizer.
Catalog Number
1596612
Brand Name
NA
Version/Model Number
15966-12
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
-
Product Code
FLE
Product Code Name
Sterilizer, steam
Public Device Record Key
36b0ce76-a6be-4b6b-8565-aa225cfdad1f
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
August 17, 2019
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 |