Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010197700

FEI Number

3010197700

Entity Name

OMNI COMPONENTS CORPORATION

City/State/Country

Hudson, NH, US

Establishment Address

46 River Rd, Hudson, NH 03051, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Omni Components Corp. (Owner Number: 10044093)

Owner / Operator Contact Address

46 River Road, Hudson, NH 03051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TUNN ROD,FULL CURVE,AV-2 TUNNELING TIP, 7MM, BLUNT TUNN ROD,CURVED,SHORT AV-1 TUNNELING TIP, 5MM TUNNELING TIP, 10MM, BLUNT TUNNELING TIP, 8MM, BLUNT Vascular Graft Tunneling Instrumentation TUNNELING TIP, 6MM, BLUNT TUNN ROD,CURVED,LONG,PV-2 TUNNELING TIP, 8MM TUNNELING TIP, 4MM TUNNELING TIP, 6MM TUNNELING TIP, 7MM TUNN ROD,CURVED,MID-LNGTH PV-1 TUNNELING TIP, 10MM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2024-06-24

Official Correspondent

Kevin Consaul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omni Components Corp.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197700. Last updated year: 2026. Please use registration number 3010197700 when referencing this establishment in official correspondence.