FDA Registration
Active
🇺🇸 United States
Tegra Medical - Dartmouth, MA
Reg #: 1219114
·
FEI: 1219114
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Tegra Medical - Dartmouth, MA
- Registration Number
- 1219114
- FEI Number
- 1219114
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8 Ledgewood Blvd
- City
- DARTMOUTH
- State
- MA
- ZIP
- 02747
- Country
- US
Owner / Operator
- Firm Name
- Tegra Medical, LLC
- Operator Number
- 10042471
- Address
- 16 Forge Parkway
- City
- Franklin
- State
- MA
- Postal Code
- 02038
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-07-15 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2016-10-19 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2012-11-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2013-01-15 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2012-11-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-04-08 |
Proprietary Names
Imbibe Bone Marrow Aspiration Needle
Tuohy needle,14 gauge
Imbibe Needle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)