Catalog Number

ENT-OTO-2.5X2.5

Brand Name

BIODESIGN

Version/Model Number

G44451

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K150594,K161000

Product Code

KHJ

Product Code Name

POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

Public Device Record Key

708dae44-b03c-4850-a950-91ef6a7409a2

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-