FDA Registration
Active
🇫🇷 France
IN'TECH MEDICAL SAS
Reg #: 9611579
·
FEI: 3002904345
·
Expires 2026
Products
51
Proprietary Names
8
Establishment Types
2
Classifications
51
Registration Details
- Registration Name
- IN'TECH MEDICAL SAS
- Registration Number
- 9611579
- FEI Number
- 3002904345
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 93-95 Avenue du Champ de Gretz
- City
- RANG DU FLIERS Pas-de-Calais
- Country
- FR
Owner / Operator
- Firm Name
- IN'TECH MEDICAL SAS
- Operator Number
- 9044399
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
- Correspondent
- Lisa Boyle
US Agent
- Business Name
- Bradshaw Medical Inc. - Intech- Exalta
- Contact Name
- Tania Shammo
- Address
- 10325 58th Pl
- City
- Kenosha
- State
- WI
- ZIP
- 53144
- Country
- US
- [email protected]
- Phone
- 262 2886450
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-06-07 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2014-05-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-05-24 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2017-02-28 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-03-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-04-28 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-02-20 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2015-05-22 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2018-05-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-01-13 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2018-05-29 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-12-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-05-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-05-15 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2023-05-31 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2023-05-31 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-06-07 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2007-05-24 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2023-05-31 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2015-05-22 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2017-04-14 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-03-26 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-05-05 |
| Fork | HXE | Class 1 | Orthopedic | No | 2025-07-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2020-10-15 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-03-26 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2015-04-10 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-02-20 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2015-05-22 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-03-26 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-03-26 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-02-05 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2007-05-24 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2015-05-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-10-15 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2007-05-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-03-26 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-02-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-03-26 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-03-26 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-03-26 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2013-03-26 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2017-03-13 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2015-05-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-05-22 |
Proprietary Names
MF854R
Reamer
FW774R ROD CALIPER
Variable Angle 3mm Hex Driver
Variable Angle 4mm Hex Driver
Cannulated T7 Driver Shaft, QC
Fitting AutoFIX 2/2.5
Depth Gauge
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)