LW Scientific, Inc - E8 Digital Portafuge Centrifuge - LW SCIENTIFIC, INC.

Duns Number:785335381

Device Description: E8 Digital Portafuge Centrifuge

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More Product Details

Catalog Number

E8C-U8AD-15TP

Brand Name

LW Scientific, Inc

Version/Model Number

E8C-U8AD-15TP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 07, 2022

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

-

Prescription Use (Rx)

-

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

84c2c115-ae0c-40e7-887d-fefdffcb4564

Public Version Date

September 08, 2022

Public Version Number

3

DI Record Publish Date

April 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LW SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 94
2 A medical device with a moderate to high risk that requires special controls. 28