FDA Device Establishments · JSON-LD · Markdown
FEI 3019766696 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3019766696 |
|---|---|
| Owner / Operator | Pristine Surgical LLC (#10088394) |
| Address | 34125 Us Hwy 19 N Ste 200, Palm Harbor, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HRX |
| Regulation § (21 CFR) | 888.1100 |
| Proprietary names | Pristine Arthroscopic Visualization System; Summit Single Use Arthroscope |
Source: openFDA. Public-domain (CC0).