FDA Registration
Active
🇺🇸 United States
J-PAC, LLC.
Reg #: 1221051
·
FEI: 1221051
·
Expires 2026
Products
22
Proprietary Names
11
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- J-PAC, LLC.
- Registration Number
- 1221051
- FEI Number
- 1221051
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25 CENTRE RD.
- City
- SOMERSWORTH
- State
- NH
- ZIP
- 03878
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180364
Owner / Operator
- Firm Name
- J-Pac Medical
- Operator Number
- 10034516
- Address
- 25 Centre Rd
- City
- Somersworth
- State
- NH
- Postal Code
- 03878
- Country
- US
- Correspondent
- Mireya Lozano
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2018-12-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2024-12-05 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2022-06-20 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2013-01-07 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2017-12-11 |
| Fluorescence Imaging For Breast Cancer Detection | SAW | Class 3 | Unknown | No | 2024-12-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-12-07 |
| Specimen/Tissue, Identification Orientation | MJI | Class 1 | Pathology | No | 2013-01-07 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2011-06-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-06-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2022-07-12 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2012-11-08 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-08-18 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2017-12-11 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2022-06-20 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2010-12-08 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2010-12-08 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2010-12-08 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-06-25 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2022-05-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
Proprietary Names
Platelet And Plasma Separator for Bone Graft Handling
Fluorescence Imaging For Breast Cancer Detection - Lumicell Direct Visualization System (DVS)
Lapiplasty
LevaLap Laparoscopic Access Device
Bioabsorbable Anchor
Clip, Iris Retractor
PROLENE (Polypropylene) 3D Patch
Snap-Off Screw System
Python Plate Left
MAXX PRP
Gentuity HF-OCT Imaging System With Vis-Rx Micro-Imaging Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Repack or Relabel Medical Device