Duns Number:625089131
Device Description: A hand-held, non-powered mechanical device intended to be used by a healthcare professiona A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
Catalog Number
-
Brand Name
CAT Pro Select
Version/Model Number
CT012
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LXM
Product Code Name
Manipulator, Plunger-Like Joint
Public Device Record Key
3dda097c-2242-4a83-a579-999a5f1ff74a
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 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 | 19 |
| U | Unclassified | 3 |