VitaPrep - Plasma Separator - Stryker Corporation

Duns Number:149183167

Device Description: Plasma Separator

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More Product Details

Catalog Number

2113-0013

Brand Name

VitaPrep

Version/Model Number

2113-0013

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2018

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P050044,P050044,P050044,P050044

Product Code Details

Product Code

LMF

Product Code Name

Agent, absorbable hemostatic, collagen based

Device Record Status

Public Device Record Key

d6aa766b-49d9-4310-8f8b-1cd79d10d1c2

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2014

Additional Identifiers

Package DI Number

30808232001243

Quantity per Package

5

Contains DI Package

00808232001242

Package Discontinue Date

June 30, 2018

Package Status

Not in Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86