Duns Number:252468293
Device Description: The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post that suppo The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post that supports a P.T.Rail.The Floor Mast is a floor mounted structural member intended to provide a mounting surface for a P.T.Rail (in cases where wall fastening is not an option). The Floor Mast is installed with appropriate fasteners to a structural floor. The P.T.Rail is height adjustable on the Floor Mast. Must use supplied fasteners to install P.T.Rail to Floor Mast. The maximum user weight for this product is 400lbs / 181kgs.
Catalog Number
01441
Brand Name
P.T. Rail: Wall Mast, Stainless Steel
Version/Model Number
PT-WRM-SS
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
31cb9b70-222a-4160-a4cd-482514d227fc
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 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 | 298 |