Travanti - This kit contains two (2) devices: 1) - TAPEMARK COMPANY, THE

Duns Number:006154595

Device Description: This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200292) Sal This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200292) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.

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More Product Details

Catalog Number

-

Brand Name

Travanti

Version/Model Number

SP

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K992708

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

e89d2354-c732-4ea7-81b8-e4ff578f2294

Public Version Date

October 30, 2020

Public Version Number

4

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TAPEMARK COMPANY, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4