Duns Number:176935203
Catalog Number
584132
Brand Name
L C B W .3MM WIRE
Version/Model Number
584132
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 12, 2018
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
EJS
Product Code Name
ALLOY, OTHER NOBLE METAL
Public Device Record Key
5d39d472-7653-4d62-8488-0f15e7d49942
Public Version Date
November 16, 2018
Public Version Number
3
DI Record Publish Date
January 27, 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 | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 485 |