Duns Number:418415568
Device Description: Disposable Subdermal Needle Electrode 14x0.38mm, Stainless Steel, 1.5m PVC parallel wire m Disposable Subdermal Needle Electrode 14x0.38mm, Stainless Steel, 1.5m PVC parallel wire multi color 10 pairs
Catalog Number
-
Brand Name
Technomed Europe
Version/Model Number
TE/S48-637
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
6cfc195b-9eb9-431c-9e07-1b64118f3bc5
Public Version Date
June 08, 2022
Public Version Number
3
DI Record Publish Date
June 16, 2017
Package DI Number
08718375864708
Quantity per Package
10
Contains DI Package
08720791370237
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 429 |