Duns Number:077801124
Device Description: COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 Upper
Catalog Number
-
Brand Name
OSE
Version/Model Number
0827-016
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
2dd16b8d-433f-49e7-b28f-e2563e5af190
Public Version Date
May 07, 2020
Public Version Number
1
DI Record Publish Date
April 29, 2020
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 | 389 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |