FDA Registration
Active
🇺🇸 United States
Jabil Inc. (Brandywine)
Reg #: 3015212339
·
FEI: 3015212339
·
Expires 2026
Products
77
Proprietary Names
63
Establishment Types
1
Classifications
77
Registration Details
- Registration Name
- Jabil Inc. (Brandywine)
- Registration Number
- 3015212339
- FEI Number
- 3015212339
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1303 Goshen Parkway
- City
- W Chester
- State
- PA
- ZIP
- 19380
- 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 |
|---|---|---|---|---|---|
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2023-06-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-04-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-04-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-04-29 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2019-04-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2019-04-28 |
| Bender | HXW | Class 1 | Orthopedic | No | 2019-04-29 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2019-04-29 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2019-04-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-04-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-04-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-04-29 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-04-29 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2019-04-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-04-29 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-04-29 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-04-29 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-04-29 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-04-29 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2019-09-20 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2019-04-29 |
| Cranial Distraction System | PBJ | Class 2 | Neurology | No | 2023-06-23 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-04-29 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2019-04-29 |
| Prosthesis, Rib Replacement | MDI | Class 2 | Orthopedic | No | 2019-04-29 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-03-08 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-04-29 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-03-04 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-08-10 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2019-04-29 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-04-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-04-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-01-15 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2019-04-29 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-04-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2019-04-29 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-04-29 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-03-08 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-04-29 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2019-04-29 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2019-04-29 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2019-04-29 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2019-04-29 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2023-06-23 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-08-13 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-04-29 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-04-29 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2019-04-29 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2019-04-29 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2019-04-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-03-08 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2019-04-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-04-29 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2019-04-29 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2019-04-29 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-04-29 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2019-04-29 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-08-14 |
Proprietary Names
CMFD Mandible
Forceps
instrument
Cannulated Reduction Tool
Stryker F1 Charger Module
HANDLE, SCALPEL
Handle
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
SYNTHES USS, CLICK`X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
stylet
hammer
Craniomaxillofacial Distraction System (CMFD)
Synthes Neuro Plate and Screw Syste
instrument, cutting, orthopedic
extracter
Bit, Drill
Depth Gauge
Zero-P VA
Synthes Zero-P VA
DePuy Synthes Retrograde Femoral Nail Advanced System
Manual Orthopedic Instruments
Instrument
surgical instrument
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
CHIA PERCPASSER, DePuy Mitek Instrument
Bending Iron
Instrument, Bending Or Contouring
tape
GENERAL AND PLASTIC SURGERY
Small Stature Ant. Cerv. Vertebral
Screwdriver
SCREWDRIVER (MULTIPLE BRANDS)
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
REAMER (MULTIPLE BRANDS)
TROCHANTERIC FIXATION NAIL (TFN)
SYNTHES USS (10MM SIDE OPENING SCREWS
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
DePuy Synthes MatrixSTERNUM Fixation System
Torque Limiting Attachment
chisel
impactor
SYNTHES(USA) SYNTHES HYBRID EXTERNA
SYNTHES UNIVERSAL SPINAL SYSTEM
USS
template
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK
Case and Tray
tray
Synthes Dual-Opening USS
cutter
Synthes Large Ex Fix, MR Cond.
HA Coated Schanz Screw
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
Depuy Synthes MAXFRAME Multi-Axial Correction System
guide
Guide, Surgical Instrument
Guide Block
Drill Sleeve
ANTERIOR CSLP SYSTEM
MANDIBLE EXTERNAL FIXATOR
Expedium, Synapse
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)