Data / Medical devices / United States / Rxcrossroads 3PL LLC
Rxcrossroads 3PL LLC: FDA-registered device maker in Shepherdsville, KY, United States, 1 510(k) clearance and 1 PMA approval
Rxcrossroads 3PL LLC is registered with the FDA (registration 3027739783) in Shepherdsville, KY, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated November 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027739783
- FEI number
- 3009348673
- Address
- 170 Clermont Road Suite A, Shepherdsville, KY, United States, 40165
- Owner or operator
- RXCROSSROADS 3PL LLC (9064837)
- Roles
- Repackager or relabeler
- First device listed
- September 2, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector, Fluid, Non-Electrically Powered | KZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tympanostomy Tube Delivery Product With Drug | QJA | 3 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 8, 2001 | K003908 | SEROJET | KZE | Substantially Equivalent | Bioject, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 25, 2019 | P190016 | Tula® System | QJA | 11 | July 31, 2026 | accessdata.fda.gov |
Compare with other makers
Updated July 31, 2026. 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.