Duns Number:079095245
Device Description: 1/4" OVAL LOOP ELEC 4" L, REG WIRE, 1/16
Catalog Number
TP4B/4
Brand Name
Oval Loop Electrode
Version/Model Number
TP4B/4
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
-
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
JOS
Product Code Name
Electrode, electrosurgical
Public Device Record Key
6f1b9ae4-79e1-4e89-bac4-190ea80d74d3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 30, 2017
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |