Catalog Number

-

Brand Name

SLM

Version/Model Number

SZD-12-35

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

K072600,K072600

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Public Device Record Key

b81dcc6e-82d5-47fb-9bd1-6c5bab1d0593

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Package DI Number

30816633024327

Quantity per Package

10

Contains DI Package

10816633024323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box