FDA Registration
Active
🇺🇸 United States
Citra Labs LLC
Reg #: 1216032
·
FEI: 1216032
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Citra Labs LLC
- Registration Number
- 1216032
- FEI Number
- 1216032
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 55 Messina Dr
- City
- Braintree
- State
- MA
- ZIP
- 02184
- Country
- US
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-06-17 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2024-06-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1993-03-18 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2018-03-23 |
| Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions | QCG | Class N | Unknown | No | 2024-06-17 |
Proprietary Names
AccuFill Bone Substitute Material, AccuFill PreFill
ETEX MIXING AND DELIVERY SYSTEM
Precision Mixing and Delivery System
N-Force Blue Mixing and Delivery System
SURGICAL INSTRUMENT
BIOMET MANUAL
Precision Cannula
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
AccuFill PF
CarriGen PF
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only