Duns Number:499490357
Device Description: Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to preserve sterility of the product. Use for one medical operation.
Catalog Number
003-400001-5
Brand Name
Corkscrew Electrode
Version/Model Number
003-400001-5
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
K934779,K934779,K934779,K934779,K934779,K934779
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
aa7533a0-98a3-474f-9f56-9f2137a6993d
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
March 23, 2018
Package DI Number
00852373007212
Quantity per Package
350
Contains DI Package
00852373007199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box