FDA Registration
Active
🇺🇸 United States
SYNCHRONIS MEDICAL LLC
Reg #: 3014527916
·
FEI: 3014527916
·
Expires 2026
Products
19
Proprietary Names
12
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- SYNCHRONIS MEDICAL LLC
- Registration Number
- 3014527916
- FEI Number
- 3014527916
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11501 Metro Airport Center drive, Suite 100
- City
- Romulus
- State
- MI
- ZIP
- 48174
- Country
- US
Owner / Operator
- Firm Name
- Synchronis Medical LLC
- Operator Number
- 10057093
- Address
- 11501 Airport Metro Airport Center Drive, Suite 100
- City
- Romulus
- State
- MI
- Postal Code
- 48174
- Country
- US
- Correspondent
- Richard Hardman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2020-03-25 |
| Chemotherapy Spill Clean-Up Kit | PWT | Class 1 | General Hospital | No | 2025-12-31 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2020-06-24 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2026-01-12 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2025-04-11 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2019-01-29 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-05-01 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2026-01-12 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2026-01-12 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2025-12-31 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2026-01-12 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2018-02-21 |
| Cricothyrotomy Kit | OGP | Class 2 | Anesthesiology | No | 2020-03-26 |
| Thoracic Catheter Insertion Tray | PYI | Class 1 | General, Plastic Surgery | No | 2020-03-26 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2019-06-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2020-03-25 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2019-03-29 |
| Blood Transfusion Kit | POQ | Class 2 | General Hospital | No | 2020-03-25 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2020-07-28 |
Proprietary Names
IV Start Kit
Chemotherapy spill clean-up kit
Chest Valve / Chest Valve Kits
Synchronis
Underpad
Blood specimen collection convenience kit
Forward Field Cricothyrotomy Kit
Field Chest Tube Insertion Kit with Halo Seal
GAX - TOURNIQUET, NONPNEUMATIC
Field Minor Surgery Kit
Field Buddy Blood Transfusion Training Kit
Minor Surgical Procedures Tray
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device