Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

11W-W0500-08AS

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)

-

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

d9f4d5a5-f61b-475a-bfd3-903d1a105204

Public Version Date

August 23, 2021

Public Version Number

3

DI Record Publish Date

November 23, 2019

Package DI Number

10385640048719

Quantity per Package

8

Contains DI Package

00385640048712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELF BOX