FDA Registration
Active
🇩🇴 Dominican Republic
CARDINAL HEALTH D.R. 203 II LTD
Reg #: 9614277
·
FEI: 3002692512
·
Expires 2026
Products
11
Proprietary Names
0
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- CARDINAL HEALTH D.R. 203 II LTD
- Registration Number
- 9614277
- FEI Number
- 3002692512
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZONA FRANCA LAS AMERICAS, AUT. LAS AMERICAS , KM22 BLDG. H3-H4 South
- City
- SANTO DOMINGO
- Country
- DO
Regulatory Submissions
- 510(k) Number
- K061308
Owner / Operator
- Firm Name
- Cardinal Health 200, LLC
- Operator Number
- 9028292
- Address
- 3651 Birchwood Drive, --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2008-04-15 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2003-07-01 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2016-04-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-08 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2001-08-10 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2023-01-24 |
| Drape, Surgical, Ent | ERY | Class 2 | General, Plastic Surgery | No | 2017-08-07 |
| Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2009-05-06 |
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device