Duns Number:826316098
Device Description: Table that can support a patient during examination or treatment. Table has an accessory Table that can support a patient during examination or treatment. Table has an accessory attachment to which a traction device can be secured (traction device not included with table).
Catalog Number
-
Brand Name
Thera-P Traction Table
Version/Model Number
TXT
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
INQ
Product Code Name
Table, Powered
Public Device Record Key
a33f674e-b2a8-4fea-be1f-57cd136624cb
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 |