Duns Number:826316098
Device Description: Non-electric, fixed height model in the ET series of treatment cabinets with an open shelf Non-electric, fixed height model in the ET series of treatment cabinets with an open shelf.
Catalog Number
-
Brand Name
Treatment Table
Version/Model Number
ET105
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"
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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
INW
Product Code Name
Table, Mechanical
Public Device Record Key
9c99b2e5-4299-44f3-803a-842a637a94e5
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 86 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |