Navagio - Tamp, Angled - Kalitec Direct LLC

Duns Number:041956211

Device Description: Tamp, Angled

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More Product Details

Catalog Number

30-K01-6040

Brand Name

Navagio

Version/Model Number

30-K01-6040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HXG

Product Code Name

Tamp

Device Record Status

Public Device Record Key

3203ebb3-0ca8-466d-a4b9-bb3a71811ea4

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KALITEC DIRECT LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1286
2 A medical device with a moderate to high risk that requires special controls. 1900