Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030691709

FEI Number

3030691709

Entity Name

NextBeam

City/State/Country

North Sioux City, SD, US

Establishment Address

301 Centennial Dr Ste 200, North Sioux City, SD 57049, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

NextBeam (Owner Number: 10087434)

Owner / Operator Contact Address

301 Centennial Dr, North Sioux City, SD 57049, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alpha-I Bandage RedDrop One ManukaPli Wound Dressing First Honey Sterile Honey Ointment; VORTEX Cyclopen Microinterventional Cyclodialysis system MANUKAtex wound dressings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-12-16
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-12-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-06
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-04-22
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-04-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-06

Official Correspondent

Nicholas Brydon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NextBeam

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
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-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA
3011280379	DONGGUAN CITY RISEN MEDICAL PRODUCTS CO., LTD	Dongguan Guangdong, CN
3003767891	PHARMAPLAST S.A.E.	ALEXANDRIA Al Iskandariyah, EG
1043542	BRECON KNITTING MILL, INC.	Talladega, AL, US
1220246	ARTHREX, INC.	Naples, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030691709. Last updated year: 2026. Please use registration number 3030691709 when referencing this establishment in official correspondence.