Darby Dental Supply, LLC
Suture Plain 3/8 NFS-2 4/0 27" Darby
1manufacturer
60catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Darby Dental Supply, LLC |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Record published | 2025-06-27 |
| Record revised | 2024-11-11 (version 5) |
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 |
|---|---|---|---|
| 5257630 | 12 | In distribution | |
| 686G | 5-0 | 12 | In distribution |
| 5257637 | 12 | In distribution | |
| 5257623 | 12 | In distribution | |
| 5257619 | 12 | In distribution | |
| 559B | 4-0 | 12 | In distribution |
| 5257621 | 12 | In distribution | |
| 5257618 | 12 | In distribution | |
| 5257633 | 12 | In distribution | |
| 592PG-DAR | 3/0 | 12 | In distribution |
| 5257625 | 12 | In distribution | |
| 543CG-DAR | 5/0 | 12 | In distribution |
| 592B | 3-0 | 12 | In distribution |
| 612PG-DAR | 3/0 | 12 | In distribution |
| 1248B | 5-0 | 12 | In distribution |
| 635CG-DAR | 4/0 | 12 | In distribution |
| 821PG-DAR | 4/0 | 12 | In distribution |
| 686PG-DAR | 5/0 | 12 | In distribution |
| 5257617 | 12 | In distribution | |
| 551B | 4-0 | 12 | In distribution |
| 5257635 | 12 | In distribution | |
| 558CG-DAR | 4/0 | 12 | In distribution |
| 591B | 4-0 | 12 | In distribution |
| 636CG-DAR | 3/0 | 12 | In distribution |
| 537B | 4-0 | 12 | In distribution |
| 544CG-DAR | 4/0 | 12 | In distribution |
| 5257629 | 12 | In distribution | |
| 594B | 3-0 | 12 | In distribution |
| 558B | 4-0 | 12 | In distribution |
| 5257632 | 12 | In distribution | |
| 546CG-DAR | 4/0 | 12 | In distribution |
| 5257636 | 12 | In distribution | |
| 1654G | 4-0 | 12 | In distribution |
| 687CG-DAR | 5/0 | 12 | In distribution |
| 593PG-DAR | 3/0 | 12 | In distribution |
| 560B | 3-0 | 12 | In distribution |
| 810PG-DAR | 3/0 | 12 | In distribution |
| 591PG-DAR | 4/0 | 12 | In distribution |
| 543B | 5-0 | 12 | In distribution |
| 5257622 | 12 | In distribution | |
| 546B | 4-0 | 12 | In distribution |
| 554B | 3-0 | 12 | In distribution |
| 1654CG-DAR | 4/0 | 12 | In distribution |
| 5257624 | 12 | In distribution | |
| 5257620 | 12 | In distribution | |
| 547CG-DAR | 4/0 | 12 | In distribution |
| 5257634 | 12 | In distribution | |
| 525CG-DAR | 3/0 | 12 | In distribution |
| 5257638 | 12 | In distribution | |
| 612G | 3-0 | 12 | In distribution |
| 535PG-DAR | 5/0 | 12 | In distribution |
| 537PG-DAR | 4/0 | 12 | In distribution |
| 5257631 | 12 | In distribution | |
| 544B | 4-0 | 12 | In distribution |
| 822PG-DAR | 3/0 | 12 | In distribution |
| 553B | 3-0 | 12 | In distribution |
| 5257626 | 12 | In distribution | |
| 547B | 4-0 | 12 | In distribution |
| 525B | 3-0 | 12 | In distribution |
| 686G | 5-0 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeGUT | Demetech Corp. | 1,421 |
| Softcat | B Braun Surgical SA | 338 |
| Ethicon | Ethicon, Inc. | 231 |
| Catgut | B Braun Surgical SA | 147 |
| Chromic Gut | Covidien LP | 142 |
| Plain Gut | Covidien LP | 68 |
| Reli® | Myco Medical Supplies, Inc. | 63 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 52 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 46 |
| Suture, Absorbable, Natural | C P Medical Inc. | 44 |
| Chromic Gut | Riverpoint Medical LLC | 33 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 30 |
Showing 12 of 237. All products under Suture, Absorbable, Natural
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N14226 | 1987-08-28 | ABSORBABLE SURGICAL SUTURE, USP | Ethicon, Inc. |
| N10389 | 1987-06-18 | ABSORBABLE SURGICAL SUTURE, USP | Ethicon, Inc. |
| N84380 | 1985-02-27 | PLAIN GUT SUTURES | Deknatel, Inc. |
| N83038 | 1984-04-27 | PLAIN GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. |
| N83433 | 1983-08-18 | CHROMIC GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. |
| N84381 | 1981-08-11 | GUT | Deknatel, Inc. |
| N8536 | 1981-01-06 | CATGUT SUTURE | Ethicon, Inc. |
| N15405 | 1981-01-06 | COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE | Ethicon, Inc. |
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.