Duns Number:103449711
Device Description: Elbow Corrective Orthosis, size Large/Right
Catalog Number
ECO-LR
Brand Name
BMI
Version/Model Number
ECO-LR
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"
-
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
IQI
Product Code Name
Orthosis, Limb Brace
Public Device Record Key
725a1214-ec0c-4fbd-89d4-755e697c059d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 10, 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 | 325 |