FDA Registration
Active
🇺🇸 United States
Nypro Inc (Maple Grove)
Reg #: 3011024991
·
FEI: 3011024991
·
Expires 2026
Products
40
Proprietary Names
55
Establishment Types
1
Classifications
40
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Registration Details
- Registration Name
- Nypro Inc (Maple Grove)
- Registration Number
- 3011024991
- FEI Number
- 3011024991
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11400 73rd Ave N Ste 100
- City
- Maple Grove
- State
- MN
- ZIP
- 55369
- Country
- US
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single-Use Reprocessed Ultrasonic Surgical Instruments | NLQ | Class U | Unknown | No | 2018-08-25 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2018-08-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2020-01-21 |
| Reprocessed Bronchoscope | QNW | Class 2 | Ear, Nose, Throat | No | 2024-01-19 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2018-08-26 |
| Clip, Implantable, Reprocessed | NMJ | Class 2 | General, Plastic Surgery | No | 2018-08-10 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-08-14 |
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2018-08-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2018-08-25 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-08-10 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2018-08-26 |
| Catheter, Recording, Electrode, Reprocessed | NLH | Class 2 | Cardiovascular | No | 2018-08-14 |
| Forceps, Biopsy, Electric, Reprocessed | NLU | Class 2 | Gastroenterology, Urology | No | 2018-08-10 |
| Laparoscope, General & Plastic Surgery, Reprocessed | NLM | Class 2 | Gastroenterology, Urology | No | 2018-08-14 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2018-08-15 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-08-13 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2018-08-10 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2018-08-26 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-01-15 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2024-11-07 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | Class 2 | Cardiovascular | No | 2021-08-24 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-08-10 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2018-08-15 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2018-08-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2018-08-15 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Pin, Fixation, Threaded, Metallic | NDM | Class 2 | Orthopedic | No | 2018-08-10 |
| Reprocessed Catheter Introducer | PNE | Class 2 | Cardiovascular | No | 2018-08-25 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2018-08-25 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2018-08-10 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-08-10 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2019-09-23 |
| Forceps, Biopsy, Non-Electric, Reprocessed | NON | Class 1 | Gastroenterology, Urology | No | 2018-08-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-08-14 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2018-08-25 |
Proprietary Names
Scalpel, ultrasonic, reprocessed
General Surgical
Electrosurgical, cutting and coagulation
J&J Reprocessed Forceps, obstetrical
Implantable Clip
Cutting and Coagulation accessories
Reprocessed electrosurgical cutting and coagulation accessories laparoscopic and endoscopic
Oximeter
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Surgical Drill
Ultrasound Catheter
J&J Reprocessed intravascular ultrasound catheter
J&J Reprocessed Knife, Ear
Catheter
Biopsy Forceps
Laparoscope
OXIMETER, REPROCESSED
LEAF Patient Monitoring System
Bed Patient Monitor
chisel
Ultrasonic Instrument, Ultrasonic Scalpel
Catheter, Recording, Electrode, Reprocessed
CATHETER, RECORDING, ELECTRODE, REPROCESSED
J&J Reprocessed Knife, Orthopedic
HANDLE, SCALPEL
Handle
Reprocessed intravascular ultrasound catheter
Manual Orthopedic Instruments
Instrument
surgical instrument
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
CHIA PERCPASSER, DePuy Mitek Instrument
Ultrasonic scalpel
Reprocessed DECANAV Electrophysiology Catheter
Catheter, recording, electrode, reprocessed
Saw Blade
LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Arthroscope
Fixation Appliance
Metallic Pin
Reprocessed catheter introducer
Catheter Introducer
Fixation Component
Ultrasonic Scalpel
Cable Electrode
Stryker F1 Charger Module
Recording Electrode
Bit, Drill
Reprocessing Recording Electrode Catheter
countersink
Depuy Synthes MAXFRAME Multi-Axial Correction System
Forceps
Cutting and Coagulation Accessories
SLEEVE, LIMB, COMPRESSIBLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)