Darby Dental Supply, LLC
Suture PTFE 3/8 C-17 5/0 18"
1manufacturer
24catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | Darby Dental Supply, LLC |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| 510(k) | K173922 |
| Record published | 2019-06-24 |
| Record revised | 2023-06-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9506994 | 12 | In distribution | |
| 5257648 | 12 | In distribution | |
| 9506992 | 12 | In distribution | |
| 5257644 | 12 | In distribution | |
| 9506993 | 12 | In distribution | |
| 9506991 | 12 | In distribution | |
| 5257641 | 12 | In distribution | |
| 9506987 | 12 | In distribution | |
| 5257640 | 12 | In distribution | |
| 9506984 | 12 | In distribution | |
| 5257646 | 12 | In distribution | |
| 9506989 | 12 | In distribution | |
| 9506990 | 12 | In distribution | |
| 5257649 | 12 | In distribution | |
| 5257643 | 12 | In distribution | |
| 9506988 | 12 | In distribution | |
| 9506983 | 12 | In distribution | |
| 9506986 | 12 | In distribution | |
| 5257639 | 12 | In distribution | |
| 5257647 | 12 | In distribution | |
| 5257642 | 12 | In distribution | |
| 9506985 | 12 | In distribution | |
| 5257645 | 12 | In distribution | |
| 9506982 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demetech PTFE | Demetech Corp. | 201 |
| Biotex | Purgo Biologics Inc. | 60 |
| Sterile PTFE Surgical Suture | Omnia Medical | 45 |
| Monotex | Riverpoint Medical LLC | 36 |
| Cytoplast™ PTFE Suture | Osteogenics Biomedical, Inc. | 34 |
| Cytosurg | Riverpoint Medical LLC | 18 |
| Unify PTFE Surgical Sutures | Applied Dental, Inc. | 13 |
| Klosure | Riverpoint Medical LLC | 10 |
| Gibson | Benco Dental Supply Co. | 9 |
| Maxima | Henry Schein, Inc. | 9 |
| Ptfe | Riverpoint Medical LLC | 9 |
| Golnit PTFE Suture | Golnit Sutures | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.