Duns Number:499490357
Device Description: Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one package o Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one package of 6 to preserve sterility of the product. Used as a set for one operation.
Catalog Number
003-400001-6
Brand Name
Corkscrew Electrode
Version/Model Number
003-400001-6
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
77f62c30-b2b1-4c6f-b1aa-e11df93a7b45
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
00852373007069
Quantity per Package
250
Contains DI Package
00852373007052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box