Catalog Number

-

Brand Name

SLM

Version/Model Number

SBB-20Z-40

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

K092554

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Public Device Record Key

2d61a107-b266-4eb0-ae8e-66f977e61cf0

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-