Duns Number:113170088
Device Description: Retainium is intended for use as a lingual retention wire.This is a single strand for samp Retainium is intended for use as a lingual retention wire.This is a single strand for sample evaluation.0.016 mm Diameter
Catalog Number
XLRETSAM
Brand Name
Retainium
Version/Model Number
XLRETSAM
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
DZC
Product Code Name
Wire, Orthodontic
Public Device Record Key
4c67cb08-67cd-45d2-8442-9fab510dd1ce
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
November 16, 2017
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |