Catalog Number

33521

Brand Name

Integra® Miltex®

Version/Model Number

33521

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

K091721

Product Code

GEH

Product Code Name

UNIT, CRYOSURGICAL, ACCESSORIES

Public Device Record Key

ab711c7c-6065-4cc7-a899-dd6d0c4a1cce

Public Version Date

July 01, 2021

Public Version Number

6

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-