Catalog Number

N14

Brand Name

EXMOOR

Version/Model Number

N14

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

-

Product Code

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

5be75609-e87d-4f53-b636-76ae11dee670

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 14, 2018

Package DI Number

05060180251222

Quantity per Package

20

Contains DI Package

05060180257583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box