Catalog Number

MH19-716

Brand Name

Integra® Miltex®

Version/Model Number

MH19-716

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

-

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

JYG

Product Code Name

CURETTE, EAR

Public Device Record Key

c46a2dc9-edeb-4fa5-bd1a-643df7c05c5d

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

April 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-