Nasal Implant - Sterile, silicone, nasal implant. - HANSON MEDICAL

Duns Number:058759296

Device Description: Sterile, silicone, nasal implant.

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More Product Details

Catalog Number

SV - 5 W

Brand Name

Nasal Implant

Version/Model Number

SV - 5 W

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090803

Product Code Details

Product Code

FZE

Product Code Name

Prosthesis, Nose, Internal

Device Record Status

Public Device Record Key

42250664-46db-48a3-a4d8-baa8c3b457a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANSON MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 592