SELPHYL® - The SELPHYL® System is designed for the safe and - Factor Medical, Inc.

Duns Number:117697569

Device Description: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-

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More Product Details

Catalog Number

440910

Brand Name

SELPHYL®

Version/Model Number

PRFM

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

BK170096,BK170096,BK170096

Product Code Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

e9134f6d-77f2-4648-ab4e-4ce042b9bd3e

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

June 05, 2020

Additional Identifiers

Package DI Number

30851802007107

Quantity per Package

10

Contains DI Package

10851802007103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"FACTOR MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6