Atramat
Atramat Chromic GUT Surgical Suture USP 6-0 EP 1, 45 CM Double Needle P-PE-13 Supra-Sharp Reverse Cutting 13 MM 3/8 Circle
1manufacturer
52catalogue 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 | Internacional Farmacéutica S.A DE C.V, Mexico |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| 510(k) | K911354 |
| Record published | 2021-03-08 |
| Record revised | 2023-11-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 65 % RH; Storage environment temperature 15 to 30 °C |
| Packaging | Dozen of 12, box with 24 packs of 24 |
| Sizes | Length 9 to 48 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CHROMIC GUT | Length 30 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| PLAIN GUT | Length 24 mm | In distribution |
| CHROMIC GUT | Length 16 mm | In distribution |
| CHROMIC GUT | Length 19 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 40 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| PLAIN GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CATGUT CROMICO | Length 9 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| PLAIN GUT | Length 17 mm | In distribution |
| CHROMIC GUT | Length 48 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 40 mm | In distribution |
| CHROMIC GUT | Length 24 mm | In distribution |
| PLAIN GUT | Length 24 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CHROMIC GUT | Length 19 mm | In distribution |
| CHROMIC GUT | Length 40 mm | In distribution |
| CHROMIC GUT | Length 17 mm | In distribution |
| CHROMIC GUT | USP 3-0 EP 3 | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| PLAIN GUT | Length 37 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 12 mm | In distribution |
| PLAIN GUT | Length 12 mm | In distribution |
| CHROMIC GUT | Length 48 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 20 mm | In distribution |
| CHROMIC GUT | Length 19 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CHROMIC GUT | Length 24 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 20 mm | In distribution |
| CHROMIC GUT | Length 19 mm | In distribution |
| CHROMIC GUT | Length 48 mm | In distribution |
| PLAIN GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CHROMIC GUT | Length 26 mm | In distribution |
| PLAIN GUT | Length 26 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CHROMIC GUT | USP 2-0 EP 3,5 | In distribution |
| CHROMIC GUT | Length 40 mm | In distribution |
| CHROMIC GUT | Length 37 mm | In distribution |
| CHROMIC GUT | Length 13 mm | 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 |
| 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.