FDA Registration
Active
🇨🇷 Costa Rica
Hologic Surgical Products Costa Rica, S.R.L.
Reg #: 3007200016
·
FEI: 3007200016
·
Expires 2026
Products
13
Proprietary Names
40
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Hologic Surgical Products Costa Rica, S.R.L.
- Registration Number
- 3007200016
- FEI Number
- 3007200016
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 562 Parkway, Ave 0, Calle 0, Coyol Free Zone
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K081179
- PMA Number
- P010013
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
US Agent
- Business Name
- Hologic
- Contact Name
- Priscilla Aguilar
- Address
- 250 Campus Drive
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 978 8263858
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2008-07-30 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-06-03 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2018-08-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-01-04 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-04-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-03-05 |
| Seal, Cervical, Mechanical, Unpowered | QHZ | Class 1 | Obstetrics/Gynecology | No | 2019-08-30 |
| Probe, Uptake, Nuclear | IZD | Class 1 | Radiology | No | 2020-01-23 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2018-08-03 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2010-06-17 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2011-03-03 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 1992-07-14 |
| Device, Thermal Ablation, Endometrial | MNB | Class 3 | Unknown | No | 2008-04-09 |
Proprietary Names
MammoSite Cavity Evaluation Device
Sertera Introducer Set
Celero Introducer Set
MammoSite 4-5 balloon & Afterloader
MammoSite Radiation Therapy System
MyoSure XL TRD for Fluent
CoolSeal Trinity
Eviva Stereotactic Breast Biopsy Device
Eviva Adapters
Celero
Sizer Set
Omni Lok
MammoSite RTS system 5-6 balloon
MyoSure
Sertera Biopsy Device
MyoSure Reach
TruNode Gamma Probe System
Fluent
SecurMark
Tissue Removal Device
Marker Wire Kit
MammoSite 4-6 balloon
MammoSite ML
CoolSeal Reveal
Fluent Pro Fluid Management System
BioZorb Marker
ATEC Console
Tissue Filter
Eviva
ATEC
Needle Guides
Introducer Localization Set (ILS)
ATEC Adapters
Trimark
NovaSure RF Controller
NovaSure Device (Handpiece)
NovaSure EndometrialAblation System
MyoSure Single Use Seals
BioZorb LP Marker
Brevera Breast Biopsy System with Corlumina Imaging Technology
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)