GD - The Prep-Check Plus, 25 pin is a hand-held, - General Devices

Duns Number:101394815

Device Description: The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the

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More Product Details

Catalog Number

EIM-107-25B

Brand Name

GD

Version/Model Number

Prep-Check Plus, 25 pin

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GZO

Product Code Name

Device, Galvanic Skin Response Measurement

Device Record Status

Public Device Record Key

d5b8dce1-be0b-4961-b7bb-a9bfbc6c4db1

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL DEVICES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10