Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012453008

FEI Number

3012453008

Entity Name

FACTOR MEDICAL Inc.

City/State/Country

Concord, MA, US

Establishment Address

300 Baker avenue, Suite 300, Concord, MA 01742, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Factor Medical, Inc (Owner Number: 10051553)

Owner / Operator Contact Address

41 University Drive, Ste 400, Newtown, PA 18940, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK170096

PMA Number

N/A

All Registered Proprietary Names

SELPHYL(R)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2018-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Factor Medical, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3033334123	FACTOR MEDICAL, INC	Newtown, PA, US

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1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US
3017065670	DERMAQUAL	Johnson City, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012453008. Last updated year: 2026. Please use registration number 3012453008 when referencing this establishment in official correspondence.