FDA Registration
Active
🇺🇸 United States
SPECTRA Sonic Block Quincke Needle
Reg #: 1224960
·
FEI: 3000204727
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPECTRA MEDICAL DEVICES, LLC
- Registration Number
- 1224960
- FEI Number
- 3000204727
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 299 Ballardvale St Ste 1
- City
- WILMINGTON
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163292
Owner / Operator
- Firm Name
- SPECTRA MEDICAL DEVICES, LLC
- Operator Number
- 9012618
- Address
- 299 BALLARDVALE STREET, SUITE 1
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2017-12-27 |
Proprietary Names
SPECTRA Sonic Block Quincke Needle
SPECTRA Sonic Block Chiba Needle
SPECTRA Sonic Block Tuohy Needle
SPECTRA Sonic Block Crawford Needle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility