Catalog Number

-

Brand Name

LATERA

Version/Model Number

LATSYS24

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161191

Product Code

NHB

Product Code Name

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Public Device Record Key

536ca89a-7878-45c8-8f9b-355361030d18

Public Version Date

January 22, 2020

Public Version Number

1

DI Record Publish Date

January 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-