Duns Number:688460539
Device Description: Electrosurgical Unit Ground Pad, Disposable, Single use, Neutral electrode, Non-corded, Ho Electrosurgical Unit Ground Pad, Disposable, Single use, Neutral electrode, Non-corded, Horizontal, Solid, Adult, 180x120mm
Catalog Number
9571C
Brand Name
PROPLATE
Version/Model Number
9571C
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"
Yes
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
K073360,K073360,K073360
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
49d83b0e-94eb-4bee-85a4-161a0d205924
Public Version Date
June 05, 2020
Public Version Number
2
DI Record Publish Date
November 12, 2019
Package DI Number
28809083941851
Quantity per Package
8
Contains DI Package
18809083941854
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |