Duns Number:176935203
Catalog Number
584130
Brand Name
LCY PDF .3MM WIRE
Version/Model Number
584130
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
EJT
Product Code Name
ALLOY, GOLD-BASED NOBLE METAL
Public Device Record Key
454ed8b0-f183-47f7-9baf-8ecfc43d9107
Public Version Date
February 07, 2019
Public Version Number
4
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 |