McKesson
SUTURE 3-0 Chromic Gut, 3-0 U.S.P. (3.0 Metric) 30"/76cm Absorbable Surgical Suture, DS18 Reverse Cutting 3/8 Circle 18 mm
1manufacturer
18catalogue 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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| 510(k) | K142656 |
| Record published | 2026-05-20 |
| Record revised | 2024-11-11 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 24, box of 12, box of 36, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M-792G | 12 | In distribution | |
| S635GX | In distribution | ||
| M-1824H | 36 | In distribution | |
| S636G | In distribution | ||
| M-1735G | 12 | In distribution | |
| M-G121H | 36 | In distribution | |
| M-796G | 12 | In distribution | |
| M-774G | 12 | In distribution | |
| M-U203H | 36 | In distribution | |
| SG122H | In distribution | ||
| M-770G | 12 | In distribution | |
| M-612G | 12 | In distribution | |
| S635G | In distribution | ||
| M-790G | 12 | In distribution | |
| S687G | In distribution | ||
| M-G122H | 36 | In distribution | |
| S1654G | In distribution | ||
| S636GX | 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| 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 |
Showing 12 of 237. All products under Suture, Absorbable, Natural
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2023-03-01 | Class II | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, | 36204 units |
| Covidien | 510(k) number | 2023-03-01 | Class II | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, | 960 units |
| Covidien | 510(k) number | 2023-03-01 | Class II | Process control | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, | 3228 units |
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.