AART Nasal Implant - Nasal Sty 3 Sterile - Aart

Duns Number:091356894

Device Description: Nasal Sty 3 Sterile

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More Product Details

Catalog Number

402-303B

Brand Name

AART Nasal Implant

Version/Model Number

B

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

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

K021418

Product Code Details

Product Code

FZE

Product Code Name

PROSTHESIS, NOSE, INTERNAL

Device Record Status

Public Device Record Key

0f56d034-c54e-4f2a-8574-40acfcb5bb9e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AART" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 371