Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226015

FEI Number

3002539629

Entity Name

VITALITEC INT'L., INC.

City/State/Country

Plymouth, MA, US

Establishment Address

10 Cordage Park Cir Suite 100, Plymouth, MA 02360, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

VITALITEC INTERNATIONAL INC. (Owner Number: 9033784)

Owner / Operator Contact Address

PREMIER PARK, 33 ROAD ONE, WINSFORD INDUSTRIAL ESTATE, WINSFORD, GB-CHE GB CW7 3R, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SLS Clip Remover CLAMPS INTRACK JAW INSERTS , CLIPS cygNet Flexible Clamp Enclose II Standard Clip Appliers Cygnet Sterilization Tray greyhouNd Adjustable clips Novaclip Spring Clip Reusable Surgical Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBQ	Instrument, Clip Removal	Neurology	Class 1	882.4200	2000-03-10
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-05-17
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2008-05-22
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2011-02-08
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2000-03-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2000-03-10
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2008-05-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2000-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VITALITEC INTERNATIONAL INC.

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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
8040233	QSA SURGICAL (PVT) LTD.	SIALKOT Punjab, PK
3010611926	TONGLU WANHE MEDICAL INSTRUMENT CO., LTD.	Hangzhou Zhejiang, CN
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
2027170	MIKRON PRECISION, INC.	GARDENA, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226015. Last updated year: 2026. Please use registration number 1226015 when referencing this establishment in official correspondence.