Duns Number:068156330
Device Description: TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2.5 FT. (0.76 TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE
Catalog Number
-
Brand Name
UltraPoint™
Version/Model Number
016393
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2019
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
IKT
Product Code Name
Electrode, Needle, Diagnostic Electromyograph
Public Device Record Key
b5358dca-16e5-411f-ba98-138b9d92f41e
Public Version Date
May 21, 2019
Public Version Number
4
DI Record Publish Date
December 07, 2016
Package DI Number
10816843024342
Quantity per Package
25
Contains DI Package
10816843024335
Package Discontinue Date
May 20, 2019
Package Status
Not 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. | 83 |