Catalog Number

-

Brand Name

ASSUREPlus®

Version/Model Number

83080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953829,K953829,K953829

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

afab5471-5c60-4262-aed5-089c24f0bad2

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

D6870083080FG2

Quantity per Package

10

Contains DI Package

D687830801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case