N/A - HOLDING MICROPIPETS - ORIGIO INC.

Duns Number:787068394

Device Description: HOLDING MICROPIPETS

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

MPH-SM-25

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

-

Product Code Details

Product Code

MQH

Product Code Name

Microtools, Assisted Reproduction (Pipettes)

Device Record Status

Public Device Record Key

8c303311-d0cb-4452-bcd1-a28e52c17e0b

Public Version Date

September 07, 2020

Public Version Number

4

DI Record Publish Date

August 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORIGIO INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 299