Duns Number:514587369
Device Description: The Vertetrac provides safe, simple, compact, and effective treatment of lumbar spine diso The Vertetrac provides safe, simple, compact, and effective treatment of lumbar spine disorders and brings to both the patient and physician a means of powerful, dynamic traction with simultaneous, three-dimensional action without the need for traction beds or restrictive braces. Thus, the Vertetrac allows the patient maximum mobility with minimal restrictions or discomfort during treatment. The Vertetrac facilitates the treatment of the patient by the health service professional while also allowing chronic sufferers to administer self-treatment under qualified medical supervision.
Catalog Number
-
Brand Name
Vertetrac
Version/Model Number
VERT9
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQE
Product Code Name
Orthosis, Lumbar
Public Device Record Key
9fbd4a3a-447e-413b-968a-3c4e4124d970
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 2022
Package DI Number
17290015711101
Quantity per Package
1
Contains DI Package
07290015711104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |