Duns Number:078375583
Device Description: Single, Auto Door, 208V, Steam
Catalog Number
-
Brand Name
Sterling P1000 Washer Disintector
Version/Model Number
P1000-S208S
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEC
Product Code Name
Disinfector, Medical Devices
Public Device Record Key
07ded3d1-c0f3-451e-afba-9e91afbaec88
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 28, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 747 |
2 | A medical device with a moderate to high risk that requires special controls. | 265 |