Duns Number:500375274
Device Description: 3mm ball; 100mm x 1.8mm electrode 1.9m wire with DIN42802 connector
Catalog Number
-
Brand Name
Globus Medical Insulated Probe 4"
Version/Model Number
675.701S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 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
c98fc981-a1ef-49d7-9536-25ebdfd9845c
Public Version Date
September 20, 2021
Public Version Number
4
DI Record Publish Date
November 24, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |