Catalog Number

-

Brand Name

STRIPPER

Version/Model Number

MXL3-IND-200

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

-

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

-

FDA Premarket Submission

K993699

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Public Device Record Key

dc209279-60bc-4d4f-966e-9b45cc723f5b

Public Version Date

November 08, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-