Duns Number:080242300
Device Description: DISPOSABLE SUREPOINT SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.8 M (72") SINGLE DISPOSABLE SUREPOINT SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.8 M (72") SINGLE LEADWIRE, COLOR GROUP C5
Catalog Number
-
Brand Name
SurePoint™
Version/Model Number
NS-S03335
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
5f9e374b-4f08-49a5-84b4-f0fe2b6d6a5b
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1261 |