FDA Registration
Active
🇺🇸 United States
Roechling Medical Lancaster, LLC
Reg #: 2531321
·
FEI: 3001237758
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- Roechling Medical Lancaster, LLC
- Registration Number
- 2531321
- FEI Number
- 3001237758
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 44 DENVER RD.
- City
- DENVER
- State
- PA
- ZIP
- 17517
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031630
Owner / Operator
- Firm Name
- Roechling Medical Rochester, L.P.
- Operator Number
- 10048821
- Address
- 999 Ridgeway Ave
- City
- Rochester
- State
- NY
- Postal Code
- 14615
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2018-07-10 |
| Allergen And Vaccine Delivery Needles | SCL | Class 2 | General Hospital | No | 2018-07-10 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-07-10 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2018-07-10 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2018-07-10 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2018-07-10 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2019-11-22 |
Proprietary Names
FILLER, BONE VOID, CALCIUM COMPOUND
BioSphere Putty Bioactive Bone Graft
SYSTEM, DELIVERY, ALLERGEN AND VACCINE
ARTHROSCOPE
CANNULA, TROCAR, OPHTHALMIC
BioSphere MIS Putty
CATHETER, CONTINUOUS FLUSH
Platelet And Plasma Separator For Bone Graft Handling
Durastat
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device