Catalog Number

90121

Brand Name

7% PVP Solution with HSA

Version/Model Number

90121-5X0.5mL

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K991343,K991343

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

66f2cabb-30d7-4515-b9ad-f0f10ad78da1

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

September 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-