Cotton Plugged IVF Pasteur Pipets - Origio, Inc. 5.75" (14.6 cm) Cotton Plugged IVF - Coopersurgical, Inc.

Duns Number:801895244

Device Description: Origio, Inc. 5.75" (14.6 cm) Cotton Plugged IVF Pasteur Pipets

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Cotton Plugged IVF Pasteur Pipets

Version/Model Number

PP-5.75-90PL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K000915,K000915

Product Code Details

Product Code

MQK

Product Code Name

Labware, Assisted Reproduction

Device Record Status

Public Device Record Key

6c66ba7a-5001-4bd0-9d9f-97347865ff44

Public Version Date

November 08, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20888937014086

Quantity per Package

30

Contains DI Package

50888937014087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COOPERSURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1471
3 A medical device with high risk that requires premarket approval 2