Duns Number:418415568
Device Description: Disposable Subdermal Needle Electrode, 13x0.4mm 2.5m twisted wire 20pairs
Catalog Number
-
Brand Name
Consolidated Neuro Supply
Version/Model Number
S44-937/02
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
707b6c55-5d10-48c7-831d-fed97dc94c61
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
08720791370299
Quantity per Package
20
Contains DI Package
08720791370282
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 429 |