Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001186500

FEI Number

3001186500

Entity Name

OVIK Health

City/State/Country

SPARTANBURG, SC, US

Establishment Address

920 Milliken Rd, SPARTANBURG, SC 29303, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K160578

PMA Number

N/A

All Registered Proprietary Names

Ultra Silver AFM Ultra Ag ComfortDry InterDry ASSIST Silver AFM Ag Assist Ultra ULTRA Border ASSIST Absorbent Pad Tritec AGILE NuStat XR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-01-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-11-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-05-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2009-06-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-10-08
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-11-17
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2019-03-26

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
3004740112	OVIK Health	Columbus, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001186500. Last updated year: 2026. Please use registration number 3001186500 when referencing this establishment in official correspondence.