Catalog Number

-

Brand Name

N/A

Version/Model Number

QPC1670

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

K131078

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

e30436e3-bbfb-4163-9e5d-056cc66e7bbd

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

March 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-