Duns Number:556196210
Device Description: 16G UTILITY PEDESTAL
Catalog Number
-
Brand Name
Utility Pedestal Assembly
Version/Model Number
ST2-271-01-004
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
04ef3cb9-78b6-4fae-ba9b-8f81adab0bec
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 2022
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 | 213 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |