FDA Device Establishments · JSON-LD · Markdown
FEI 3018064853 · Manufacture Medical Device · Status: Active
| FEI Number | 3018064853 |
|---|---|
| Owner / Operator | CPT SUTURES CO., LTD. (#10080643) |
| Address | 8 Dao Tri Street, Phu Thuan Ward, Ho Chi Minh, 700000, VN |
| Mandatory US Agent | RAF SOLUTIONS INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GAM |
| Regulation § (21 CFR) | 878.4493 |
| Proprietary names | CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture; TEKSYN® 910 - Polyglactin 910 (PGLA); Rapid (fast absorbing); CARESORB® - Polyglactin 910; CARESORB® RAPID (fast absorbing); TEKSYN® PGA - Polyglycolic Acid (PGA); Rapid, Synthetic Absorbable Suture |
Source: openFDA. Public-domain (CC0).