Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005581234

FEI Number

3005581234

Entity Name

Nelipak Healthcare Packaging

City/State/Country

CLARA, Offaly, IE

Establishment Address

KILBEGGAN ROAD, CLARA, Offaly --, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nelipak Healthcare Packaging (Owner Number: 9082522)

Owner / Operator Contact Address

KILBEGGAN ROAD, --, CLARA, CO.OFFALY, IE-NOTA R35 F583, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary name Stryker Injectable Cement No proprietary name No proprietary name No proprietary name No proprietary name No proprietary name

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-11-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-23
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2014-04-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-04-08
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2013-02-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-07
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2013-02-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2006-02-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2006-02-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2006-02-02
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2017-01-19

Official Correspondent

Acton Moore

US Agent Details

Rolando Salas Business: Nelipak Healthcare Packaging Email: rolando.salas@nelipak.com Phone: (401) 9462699

Related Public Records

Same Entity

Nelipak Healthcare Packaging

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
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005581234. Last updated year: 2026. Please use registration number 3005581234 when referencing this establishment in official correspondence.