Catalog Number

SP004

Brand Name

SPIWay

Version/Model Number

SP004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180141,K180141

Product Code

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

ca4af77a-8ba2-4294-9590-24641d7cec4e

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

August 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-