FDA Registration
Active
🇺🇸 United States
GCB MEDICAL LLC
Reg #: 3030419987
·
FEI: 3030419987
·
Expires 2026
Products
10
Proprietary Names
0
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- GCB MEDICAL LLC
- Registration Number
- 3030419987
- FEI Number
- 3030419987
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 25 Depot St
- City
- Duxbury
- State
- MA
- ZIP
- 02332
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213177
Owner / Operator
- Firm Name
- GCB Medical LLC
- Operator Number
- 10090007
- Address
- 25 Depot St
- City
- Duxbury
- State
- MA
- Postal Code
- 02332
- Country
- US
- Correspondent
- Jeff Willink
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2025-07-29 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-07-01 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-07-01 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2025-07-01 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-08-08 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-08-08 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-07-01 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-07-01 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-02-01 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-07-01 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility