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 Number3007766601
FEI Number3007766601
NameSTERIPACK MEDICAL POLAND SP. Z O.O.
Owner & OperatorSteriPack Medical Poland Sp. z o.o.
Contact AddressLeg, ul. Japonska 1
Jelcz-Laskowice PL-NOTA 55-220 PL
Official Correspondent
  • Adam Sztaba
  • 048-71-3818180-x
US Agent
Importing Logistics Registration
ImporterETHICON INC.
AddressRoute 22 West
Somerville, NJ 08876 UNITED STATES
Importing Logistics Registration
ImporterneoSurgical Inc.
Address820 East Terra Cotta Ave Ste. 149
Crystal Lake, IL 60014 UNITED STATES
Email Addressjimk@neosurgical.com
Phone1 815 8936153
Importer TypeUS Authorized Representative
Importing Logistics Registration
ImporterORTHO-MCNEIL-JANSSEN PHARMACEUTICALS INC.
Address1125 Trenton-Harbourton Road
Titusville, NJ 08560 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterSteriPack USA (Limited) LLC
Address4255 South Pipkin Road
Lakeland, FL 33811 UNITED STATES
Email Addresse.allen@steripackgroup.com
Phone1 863 6482333 113
FAX1 863 6482999
Importer TypeAGENT
Importing Logistics Registration
ImporterStryker Navigation
Address4100 East Milham Avenue
Kalamazoo, MI 49001 UNITED STATES
Phone1 616 3245346
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLeg, 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
DeviceDate
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2024-03-06
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2024-03-06
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2024-03-06
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2024-03-06
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2024-03-06
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2019-11-11
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2019-11-11
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2019-11-11
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2019-11-11
STERIPACK MEDICAL POLAND SP Z O O
Safety Needle 2019-11-11
STERIPACK MEDICAL POLAND SP. Z O.O.
Transducer Cover2017-04-19
STERIPACK MEDICAL POLAND SP. Z O.O.
Rapid-i Kit2017-04-19
STERIPACK MEDICAL POLAND SP. Z O.O.
SURGIFLO? Hemostatic Matrix Kit2015-04-08
STERIPACK MEDICAL POLAND SP. Z O.O.
MER Cable, Micro Electrode Recording Cable2015-03-03
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose Hasson 8/10 Port Closure Kit (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose Hasson 10/12 Port Closure Kit (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide XL Port Closure Kit (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide Regular Port Closure Kit X2 (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide Regular Port Closure Kit (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide 8/15 Port Closure Kit (1 Port) (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide 5/15 Port Closure Kit (2 Ports) (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide 5/12 Port Closure Kit (1 Port) (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose 4 AutoAnchor Pack (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose 2 AutoAnchor Pack (US)2015-01-09
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFESS? Straight Suction2014-09-18
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFESS? Registration Kit2014-09-18
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFESS? Frontal Sinus Seeker2014-09-18
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFESS? Curved 90 Suction2014-09-18
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFESS? Curved 70 Suction2014-09-18
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose AnchorGuide2014-01-30
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose Universal2013-06-05
STERIPACK MEDICAL POLAND SP. Z O.O.
neoClose Hasson2013-06-05
STERIPACK MEDICAL POLAND SP. Z O.O.
ARIA NM PROBE/GUIDE WIRE2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
ARIA DILATOR 6.5MM2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
ARIA DILATOR 22.5MM2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
ARIA DILATOR 14.5MM NM2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
T2 - INSTRUMENTS2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
GAMMA3 - INSTRUMENTS2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
BATTERY PACK FOR VariSpeed2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
BATTERY PACK 2 FOR QUIKDRIVE2013-01-22
STERIPACK MEDICAL POLAND SP. Z O.O.
PROFORE2012-11-23
STERIPACK MEDICAL POLAND SP. Z O.O.
Catheter, Continuous Flush2012-11-16

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020032313328Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaPACKING MACHINE3 CTN
2018112650719Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaNOTEBOOKS, NEEDLES,STICKERS & MACHINE HS CODE: 482020, 901832, 391990, 854370 CARGO LOADED IN GDANSK ON THE 31.10.2018 ONTO MAJESTIC MAERSK844 E FREIGHT PREPAID6 PKG

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