Steripack Medical Poland Sp Z O O

FDA Filings

This page includes the latest FDA filings for Steripack Medical Poland Sp Z O O. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3007766601

FEI Number

3007766601

Name

STERIPACK MEDICAL POLAND SP. Z O.O.

Owner & Operator

SteriPack Medical Poland Sp. z o.o.

Contact Address

Leg, ul. Japonska 1
Jelcz-Laskowice PL-NOTA 55-220 PL

Official Correspondent

Adam Sztaba
048-71-3818180-x

US Agent

Edward Allen
SteriPack USA Limited
863 6482333 113
863 6482999
e.allen@steripackgroup.com

Importing Logistics Registration

Importer	ETHICON INC.
Address	Route 22 West Somerville, NJ 08876 UNITED STATES

Importing Logistics Registration

Importer	neoSurgical Inc.
Address	820 East Terra Cotta Ave Ste. 149 Crystal Lake, IL 60014 UNITED STATES
Email Address	jimk@neosurgical.com
Phone	1 815 8936153
Importer Type	US Authorized Representative

Importing Logistics Registration

Importer	ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS INC.
Address	1125 Trenton-Harbourton Road Titusville, NJ 08560 UNITED STATES
Importer Type	Agent

Importing Logistics Registration

Importer	SteriPack USA (Limited) LLC
Address	4255 South Pipkin Road Lakeland, FL 33811 UNITED STATES
Email Address	e.allen@steripackgroup.com
Phone	1 863 6482333 113
FAX	1 863 6482999
Importer Type	AGENT

Importing Logistics Registration

Importer	Stryker Navigation
Address	4100 East Milham Avenue Kalamazoo, MI 49001 UNITED STATES
Phone	1 616 3245346

Registration Status

1

Initial Importer

N

Registration Expiration

2020-04-25

Registration Address

Leg, ul. Japonska 1
Jelcz-Laskowice Dolnoslaskie, 55-220 PL

Establishment Type

Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 05907527942187 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2024-03-06
GUDID 05907527942071 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2024-03-06
GUDID 05907527942064 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2024-03-06
GUDID 05907527942019 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2024-03-06
GUDID 05907527942002 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2024-03-06
GUDID 05907527942194 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2019-11-11
GUDID 05907527942095 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2019-11-11
GUDID 05907527942088 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2019-11-11
GUDID 05907527942033 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2019-11-11
GUDID 05907527942026 STERIPACK MEDICAL POLAND SP Z O O	Safety Needle	2019-11-11
PMN K862364 \| HEM STERIPACK MEDICAL POLAND SP. Z O.O.	Transducer Cover	2017-04-19
PMN K090832 \| MQK STERIPACK MEDICAL POLAND SP. Z O.O.	Rapid-i Kit	2017-04-19
PMN P990004 \| LMF STERIPACK MEDICAL POLAND SP. Z O.O.	SURGIFLO? Hemostatic Matrix Kit	2015-04-08
IKD STERIPACK MEDICAL POLAND SP. Z O.O.	MER Cable, Micro Electrode Recording Cable	2015-03-03
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose Hasson 8/10 Port Closure Kit (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose Hasson 10/12 Port Closure Kit (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide XL Port Closure Kit (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide Regular Port Closure Kit X2 (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide Regular Port Closure Kit (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide 8/15 Port Closure Kit (1 Port) (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide 5/15 Port Closure Kit (2 Ports) (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide 5/12 Port Closure Kit (1 Port) (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose 4 AutoAnchor Pack (US)	2015-01-09
PMN K142903 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose 2 AutoAnchor Pack (US)	2015-01-09
PMN K141551 \| PGW STERIPACK MEDICAL POLAND SP. Z O.O.	PROFESS? Straight Suction	2014-09-18
PMN K141551 \| PGW STERIPACK MEDICAL POLAND SP. Z O.O.	PROFESS? Registration Kit	2014-09-18
PMN K141551 \| PGW STERIPACK MEDICAL POLAND SP. Z O.O.	PROFESS? Frontal Sinus Seeker	2014-09-18
PMN K141551 \| PGW STERIPACK MEDICAL POLAND SP. Z O.O.	PROFESS? Curved 90 Suction	2014-09-18
PMN K141551 \| PGW STERIPACK MEDICAL POLAND SP. Z O.O.	PROFESS? Curved 70 Suction	2014-09-18
GDF STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose AnchorGuide	2014-01-30
PMN K123280 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose Universal	2013-06-05
PMN K123280 \| GCJ STERIPACK MEDICAL POLAND SP. Z O.O.	neoClose Hasson	2013-06-05
PMN K110419 \| GXZ STERIPACK MEDICAL POLAND SP. Z O.O.	ARIA NM PROBE/GUIDE WIRE	2013-01-22
PMN K110419 \| GXZ STERIPACK MEDICAL POLAND SP. Z O.O.	ARIA DILATOR 6.5MM	2013-01-22
PMN K110419 \| GXZ STERIPACK MEDICAL POLAND SP. Z O.O.	ARIA DILATOR 22.5MM	2013-01-22
PMN K101051 \| MAX STERIPACK MEDICAL POLAND SP. Z O.O.	ARIA DILATOR 14.5MM NM	2013-01-22
LXH STERIPACK MEDICAL POLAND SP. Z O.O.	T2 - INSTRUMENTS	2013-01-22
LXH STERIPACK MEDICAL POLAND SP. Z O.O.	GAMMA3 - INSTRUMENTS	2013-01-22
GEY STERIPACK MEDICAL POLAND SP. Z O.O.	BATTERY PACK FOR VariSpeed	2013-01-22
GEY STERIPACK MEDICAL POLAND SP. Z O.O.	BATTERY PACK 2 FOR QUIKDRIVE	2013-01-22
FQM STERIPACK MEDICAL POLAND SP. Z O.O.	PROFORE	2012-11-23
PMN K071468 \| KRA STERIPACK MEDICAL POLAND SP. Z O.O.	Catheter, Continuous Flush	2012-11-16

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020032313328	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	PACKING MACHINE	3 CTN
2018112650719	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	NOTEBOOKS, NEEDLES,STICKERS & MACHINE HS CODE: 482020, 901832, 391990, 854370 CARGO LOADED IN GDANSK ON THE 31.10.2018 ONTO MAJESTIC MAERSK844 E FREIGHT PREPAID	6 PKG

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