Catalog Number

DCMD0001

Brand Name

nasasponge

Version/Model Number

DCMD0001

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"

Yes

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

-

Product Code

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

502a6a61-22b8-46a4-b06b-5d2f5239b88c

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Package DI Number

26974413960016

Quantity per Package

2

Contains DI Package

06974413960012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box