Duns Number:019872358
Catalog Number
-
Brand Name
Neutral Plate
Version/Model Number
IEC-NPD/1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
0c4ce2cc-07ac-4fe8-b9d3-625b324f264c
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
00846338001308
Quantity per Package
25
Contains DI Package
00846338010874
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box (IEC-NPD)
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 98 |