Catalog Number

-

Brand Name

LATERA

Version/Model Number

LATANI02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NHB

Product Code Name

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Public Device Record Key

5ffa80ff-9d39-405d-a8d8-1bf96e199c05

Public Version Date

September 21, 2020

Public Version Number

5

DI Record Publish Date

July 21, 2016

Package DI Number

00857037006969

Quantity per Package

6

Contains DI Package

00857037006044

Package Discontinue Date

September 18, 2020

Package Status

Not in Commercial Distribution

Package Type

-