Duns Number:068156330
Device Description: DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLO DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 3
Catalog Number
-
Brand Name
Rochester
Version/Model Number
S82015-PT3-20RM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2018
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
cfc079ca-fe05-49bf-a456-efdac5cf43b4
Public Version Date
October 16, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10816843023314
Quantity per Package
20
Contains DI Package
10816843023321
Package Discontinue Date
October 15, 2018
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 |