Duns Number:020956330
Device Description: .020 A.J. WILCOCK AUSTRALIAN REGULAR + STAINLESS STEEL 25' SPL
Catalog Number
229-207
Brand Name
A.J Wilcock Stainless Steel Archwire
Version/Model Number
229-207
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
cb43319f-78b1-46c8-9732-921176db7aa3
Public Version Date
January 26, 2022
Public Version Number
1
DI Record Publish Date
January 18, 2022
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 |