Duns Number:084042331
Device Description: The Tailback 42 is a universal spinal orthosis designed with our patent pending chord comp The Tailback 42 is a universal spinal orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a low profile, comfortable, and quick fitting solution for patient. Ice pack included.Easy application, universal sizeRemovable ice packLightweight, latex free breathable materialSingle pulley system
Catalog Number
TB042
Brand Name
ManaMed
Version/Model Number
Tailback 42
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)
Yes
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
c7e60ec9-84a9-4dc2-b41d-26f08c74ab00
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |