FDA Registration
Active
🇵🇱 Poland
STERIPACK MEDICAL POLAND SP. Z O.O.
Reg #: 3007766601
·
FEI: 3007766601
·
Expires 2026
Products
20
Proprietary Names
32
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- STERIPACK MEDICAL POLAND SP. Z O.O.
- Registration Number
- 3007766601
- FEI Number
- 3007766601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Leg, ul. Japonska 1
- City
- Jelcz-Laskowice Dolnoslaskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K012736
Owner / Operator
- Firm Name
- SteriPack Medical Poland Sp. z o.o.
- Operator Number
- 10029329
- Address
- Leg, ul. Japonska 1
- City
- Jelcz-Laskowice
- State
- PL-NOTA
- Postal Code
- 55-220
- Country
- PL
- Correspondent
- Sylwia Guszpit
US Agent
- Business Name
- SteriPack USA (Limited) LLC
- Contact Name
- Marinela Cebic
- Address
- 4255 S Pipkin Rd
- City
- Lakeland
- State
- FL
- ZIP
- 33811
- Country
- US
- [email protected]
- Phone
- 863 6482333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2013-01-22 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2017-08-02 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2021-07-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-07-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-22 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2021-02-01 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2009-05-01 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2023-09-01 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2023-09-01 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2012-11-23 |
| Blood Detection Capsule | QUD | Class 2 | Gastroenterology, Urology | No | 2023-06-14 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-02-01 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-01-22 |
| Imager, Ultrasonic Obstetric-Gynecologic | HEM | Class 2 | Obstetrics/Gynecology | No | 2017-04-19 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2015-03-03 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2015-04-08 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2014-01-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-06-05 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-01-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-07-20 |
Proprietary Names
ARIA NM PROBE/GUIDE WIRE
ARIA DILATOR 6.5MM
ARIA DILATOR 22.5MM
DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm
DePuy Synthes Tibial Nail Advanced System
GAMMA3 - INSTRUMENTS
Orthopedic Manual Surgical Instrument
T2 - INSTRUMENTS
Rapid-I Kit
PROFORE
Pill Sense System
Sterile Polyester Spun Swab
ARIA DILATOR 14.5MM NM
Transducer Cover
MER Cable, Micro Electrode Recording Cable
SURGIFLO® Hemostatic Matrix Kit
neoClose AnchorGuide
neoClose Hasson
neoClose Universal
BATTERY PACK FOR VariSpeed
BATTERY PACK 2 FOR QUIKDRIVE
neoClose AnchorGuide 5/12 Port Closure Kit (1 Port) (US)
neoClose AnchorGuide 8/15 Port Closure Kit (1 Port) (US)
neoClose AnchorGuide Regular Port Closure Kit (US)
neoClose Hasson 10/12 Port Closure Kit (US)
neoClose Hasson 8/10 Port Closure Kit (US)
neoClose 4 AutoAnchor Pack (US)
neoClose AnchorGuide 5/15 Port Closure Kit (2 Ports) (US)
neoClose AnchorGuide Regular Port Closure Kit X2 (US)
neoClose 2 AutoAnchor Pack (US)
neoClose AnchorGuide XL Port Closure Kit (US)
Bit, Drill
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device