Catalog Number

-

Brand Name

Handling Pipette

Version/Model Number

15538

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

K991104,K991104

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Public Device Record Key

cb329c22-fddd-4d8e-b4dc-d5c73082a959

Public Version Date

September 13, 2021

Public Version Number

1

DI Record Publish Date

September 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-