Catalog Number

N8

Brand Name

EXMOOR

Version/Model Number

N8

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

7a086019-b5d8-464b-b495-99950416ab6d

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 14, 2018

Package DI Number

05060180251161

Quantity per Package

20

Contains DI Package

05060180257651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box