Duns Number:020956330
Device Description: 9MM CONSTANT FORCE NITINOL SPRING - MEDIUM FORCE (5)
Catalog Number
226-292
Brand Name
Constant Force Nickel Titanium Spring
Version/Model Number
226-292
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
Yes
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
ECO
Product Code Name
Spring, Orthodontic
Public Device Record Key
e8805917-4a63-4473-b86d-b0cd0c154068
Public Version Date
December 28, 2021
Public Version Number
1
DI Record Publish Date
December 20, 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 | 1814 |
2 | A medical device with a moderate to high risk that requires special controls. | 130 |