Duns Number:007941230
Device Description: Pencil Electrosurgical Button Switch With Holster 10 Foot Cord With Universal 3-Prong Conn Pencil Electrosurgical Button Switch With Holster 10 Foot Cord With Universal 3-Prong Connector And Polytetrafluoroethylene Blade Electrode 2.5 Inch Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
ES8000
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
K081647,K081647
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
4d629b6a-5b46-4785-b9a4-289410d3a5c3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632110113
Quantity per Package
50
Contains DI Package
10885632110115
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |