LW Scientific, Inc. - Platelet Rotator 12 Bag - LW SCIENTIFIC, INC.

Duns Number:785335381

Device Description: Platelet Rotator 12 Bag

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More Product Details

Catalog Number

RTL-PLV1-12B1

Brand Name

LW Scientific, Inc.

Version/Model Number

RTL-PLV1-12B1

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

-

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

f070005a-5010-4927-85b7-fae79ddbaf2f

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 09, 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