ActivaPatch IntelliDose 2.5 Sample - ActivaPatch IntelliDose 2.5 Sample Pack (2) - ACTIVATEK INC.

Duns Number:790584176

Device Description: ActivaPatch IntelliDose 2.5 Sample Pack (2)

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More Product Details

Catalog Number

SA89188

Brand Name

ActivaPatch IntelliDose 2.5 Sample

Version/Model Number

00140-SAMPLE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

EGJ

Product Code Name

Device, Iontophoresis, Other Uses

Device Record Status

Public Device Record Key

d51966a7-4d7f-4242-914c-836e2fa0cc01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2016

Additional Identifiers

Package DI Number

10859975005155

Quantity per Package

20

Contains DI Package

00859975005158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton

"ACTIVATEK INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7