FDA Registration
Active
🇺🇸 United States
TYRO MEDICAL, LLC
Reg #: 3027588012
·
FEI: 3027588012
·
Expires 2026
Products
4
Proprietary Names
31
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TYRO MEDICAL, LLC
- Registration Number
- 3027588012
- FEI Number
- 3027588012
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 14 Rochambeau Avenue
- City
- Ridgefield
- State
- CT
- ZIP
- 06877
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243041
Owner / Operator
- Firm Name
- Tyro Medical, LLC
- Operator Number
- 10088272
- Address
- 14 Rochambeau Avenue
- City
- Ridgefield
- State
- CT
- Postal Code
- 06877
- Country
- US
- Correspondent
- david rothkopf
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-06-29 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2025-07-31 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2025-07-24 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2023-08-07 |
Proprietary Names
Tyro C-Arm Drape
PC3-VB10-RC
PC3-SCSA-3
Dynamis Surgical Arm Drape
PC3-VB10-E
Dynamis Scout Arm Drape
PC3-VB10-SC
Dynamis Cart Drape
PC2-SD-3
Dynamis Control Screen Drape
KK70L150S
KK100L50S
BC4508S
KK45R50S
KK70L50S
BC4508U
KK100L150S
BC7008U
KK45R150S
BC7008S
KK100L21S
KK70L21S
KK45R21S
BC1001U
BC1001S
Contact Forte Alpha
Contact Star
Contact Mini
Contact AN Evo
Contact Forte
UroDapter / MID-ii
Establishment Types
Complaint File Establishment per 21 CFR 820.198