Duns Number:103449711
Device Description: Knee Corrective Orthosis, size Petite-Left
Catalog Number
-
Brand Name
BMI
Version/Model Number
KCO-PL
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
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
d1d27cdb-756c-439b-8ae8-ddbca4b39162
Public Version Date
August 30, 2022
Public Version Number
3
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 |