Duns Number:084042331
Device Description: The gOAt is a universally sized, low-profile, lightweight option for patients with moderat The gOAt is a universally sized, low-profile, lightweight option for patients with moderate knee arthritis.Universal sizingRight and left SpecificOne brace does medial and lateral offloadingBreathable and low-profile neoprene
Catalog Number
GOATL
Brand Name
ManaMed
Version/Model Number
GOATL
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"
Yes
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
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
ec9241f5-faa2-47c7-a257-8d5dfd7f1957
Public Version Date
August 30, 2022
Public Version Number
2
DI Record Publish Date
June 08, 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 |