TPC - DNA Injection Pipette - Coopersurgical, Inc.

Duns Number:801895244

Device Description: DNA Injection Pipette

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More Product Details

Catalog Number

-

Brand Name

TPC

Version/Model Number

LIC-OD1

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

PUC

Product Code Name

Microtools, Assisted Reproduction (Pipettes), Exempt

Device Record Status

Public Device Record Key

713b5e4d-c760-4c56-a24d-a91ba9dc40ad

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

20888937023262

Quantity per Package

10

Contains DI Package

00888937023268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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