Duns Number:499490357
Device Description: Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired ele Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.
Catalog Number
003-400124-3
Brand Name
Twisted Pair Needle Electrode
Version/Model Number
003-400124-3
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
K010019,K010019,K010019,K010019,K010019,K010019
Product Code
IKT
Product Code Name
Electrode, Needle, Diagnostic Electromyograph
Public Device Record Key
a42e6315-0d7b-4d30-9739-2b8e40a37f7e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
00852373007090
Quantity per Package
250
Contains DI Package
00852373007083
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box