Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009394411

FEI Number

3009394411

Entity Name

OSNovative Systems, Inc.

City/State/Country

Santa Clara, CA, US

Establishment Address

500 Laurelwood Rd Ste 1, Santa Clara, CA 95054, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osnovative Systems, Inc. (Owner Number: 10039195)

Owner / Operator Contact Address

500 Laurelwood Rd., Ste 1, Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENLUXTRA Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2011-12-16

Official Correspondent

Oleg Siniaguine

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Osnovative Systems, Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009394411. Last updated year: 2026. Please use registration number 3009394411 when referencing this establishment in official correspondence.