Catalog Number

7-71-T5NI15/20

Brand Name

RI Pipettes

Version/Model Number

ICSI-Plus Non-Spiked Injection

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

K991261,K991261

Product Code

MQH

Product Code Name

MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)

Public Device Record Key

d4e54807-892b-4000-af30-7caaca65691e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-