Duns Number:418415568
Device Description: Disposable Subdermal Needle Electrode corkscrew, 1.5m twisted wire, 12pairs with Protectio Disposable Subdermal Needle Electrode corkscrew, 1.5m twisted wire, 12pairs with Protection Cap
Catalog Number
-
Brand Name
Technomed Europe
Version/Model Number
TE/S50725-004-C
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
870a54dd-8607-4079-99c2-c6d745ae33ad
Public Version Date
March 04, 2021
Public Version Number
1
DI Record Publish Date
February 24, 2021
Package DI Number
08718375867877
Quantity per Package
12
Contains DI Package
08718375867938
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 |