Duns Number:101394815
Device Description: The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female "D" Connector (All 25 Pins Wired) .
Catalog Number
EIM-107-25B
Brand Name
GD
Version/Model Number
Prep-Check Plus, 25 pin
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 23, 2016
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993202
Product Code
GZO
Product Code Name
Device, Galvanic Skin Response Measurement
Public Device Record Key
84907577-a024-4129-b1c2-89f436414fe3
Public Version Date
April 03, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |