Duns Number:606173334
Device Description: Round 10ft
Catalog Number
N081020
Brand Name
Stainless Steel Wire
Version/Model Number
20 Gauge
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 23, 2022
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)
-
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
d1c99ba8-8329-4071-a7f6-1b3c7d847db4
Public Version Date
May 24, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2018
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 | 57 |
2 | A medical device with a moderate to high risk that requires special controls. | 19532 |