Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004740112

FEI Number

3004740112

Entity Name

OVIK Health

City/State/Country

Columbus, NC, US

Establishment Address

960 East NC 108 Highway, Columbus, NC 28722, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OVIK Health (Owner Number: 9073743)

Owner / Operator Contact Address

920 MILLIKEN ROAD, Spartanburg, SC 29303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NuStat XR CoFlex TLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2019-03-26
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-11-19

Official Correspondent

Sherry Albritton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OVIK Health

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001186500	OVIK Health	SPARTANBURG, SC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Similar Registrations

Registration Number	Establishment Name	Location
3009348684	Beeken Biomedical LLC	Newton, MA, US
3006113097	T-SCIENTIFIC INTERNATIONAL, INC.	SANTO DOMINGO Distrito Nacional, DO
3005378067	VEXXUS MEDICAL INC.	SANTO DOMINGO Distrito Nacional, DO
1018233	C.R. BARD, INC.	COVINGTON, GA, US
9614493	MEDTRADE PRODUCTS LTD.	CHESHIRE Cheshire East, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004740112. Last updated year: 2026. Please use registration number 3004740112 when referencing this establishment in official correspondence.