Data / Medical devices / Dominican Republic / Cardinal Health D.R. 203 Ii Ltd
Cardinal Health D.R. 203 Ii Ltd: FDA-registered device maker in Santo Domingo, Dominican Republic, 2 510(k) clearances
Cardinal Health D.R. 203 Ii Ltd is registered with the FDA (registration 9614277) in Santo Domingo, Dominican Republic. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614277
- FEI number
- 3002692512
- Address
- ZONA FRANCA LAS AMERICAS AUT. LAS AMERICAS, KM22 BLDG. H3-H4 South, Santo Domingo, Dominican Republic, --
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- August 10, 2001
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Patient, Ophthalmic | HMT | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Ent | ERY | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Urological, Disposable | EYY | 2 | Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Stocking, Elastic | ILG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2017 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| June 5, 2006 | K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N | FYA | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Ent
- All makers of Bedding, Disposable, Medical
- All makers of Drape, Patient, Ophthalmic
- All makers of Drape, Urological, Disposable
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Exempt
Updated June 9, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.