Reli®
REDIGUT Chromic Gut Suture 3-0 YFS-2 27"
1manufacturer
63catalogue numbers in this listing
1510(k) clearance
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 | Myco Medical Supplies, Inc., United States |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Record published | 2019-05-13 |
| Record revised | 2021-02-05 (version 3) |
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 |
| Storage | Special storage condition: Recommended to be stored below 86°F (30°C), away from moisture and direct heat. |
| Packaging | Case of 30, inner carton of 12 |
| Sizes | Length 10 to 30 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GC1636-M | Length 18 in | In distribution |
| GP612-BRC | Length 18 in | In distribution |
| GP531-M | Length 10 in | In distribution |
| GC687-M | Length 18 in | In distribution |
| GC421-M | Length 30 in | In distribution |
| GC687-P | Length 18 in | In distribution |
| GP3247-M | Length 30 in | In distribution |
| GP8881-BRC | Length 18 in | In distribution |
| GC543-M | Length 18 in | In distribution |
| GC884-M | Length 30 in | In distribution |
| GC621-BRC | Length 18 in | In distribution |
| GP822-M | Length 30 in | In distribution |
| GC1654-M | Length 18 in | In distribution |
| GP1916-M | Length 18 in | In distribution |
| GC6354-M | Length 18 in | In distribution |
| GP1644-P | Length 18 in | In distribution |
| GC636-M | Length 30 in | In distribution |
| GP774-M | Length 18 in | In distribution |
| GP774-P | Length 18 in | In distribution |
| GP686-BRC | Length 18 in | In distribution |
| GC634-M | Length 30 in | In distribution |
| GC638-M | Length 30 in | In distribution |
| GP686-P | Length 18 in | In distribution |
| GC1637-M | Length 18 in | In distribution |
| GC546-M | Length 18 in | In distribution |
| GC635-BRC | Length 27 in | In distribution |
| GP531-BRC | Length 10 in | In distribution |
| GC1816-M | Length 18 in | In distribution |
| GP820-M | Length 30 in | In distribution |
| GC687-BRC | Length 18 in | In distribution |
| GC6354-BRC | Length 18 in | In distribution |
| GC6364-M | Length 18 in | In distribution |
| GP324-BRC | Length 18 in | In distribution |
| GP8881-M | Length 18 in | In distribution |
| GC421-BRC | Length 27 in | In distribution |
| GC636-P | Length 27 in | In distribution |
| GC1638-M | Length 30 in | In distribution |
| GP822-BRC | Length 27 in | In distribution |
| GP821-BRC | Length 27 in | In distribution |
| GC1638-P | Length 27 in | In distribution |
| GP7771-BRC | Length 18 in | In distribution |
| GP7771-M | Length 18 in | In distribution |
| GP1644-M | Length 18 in | In distribution |
| GC122-M | Length 30 in | In distribution |
| GC634-BRC | Length 27 in | In distribution |
| GC636-BRC | Length 27 in | In distribution |
| GC6364-BRC | Length 18 in | In distribution |
| GC203-M | Length 30 in | In distribution |
| GC635-M | Length 30 in | In distribution |
| GP821-M | Length 30 in | In distribution |
| GC621-M | Length 18 in | In distribution |
| GP1915-M | Length 18 in | In distribution |
| GC1654-P | Length 18 in | In distribution |
| GP820-BRC | Length 27 in | In distribution |
| GP324-M | Length 18 in | In distribution |
| GP3247-BRC | Length 27 in | In distribution |
| GC635-P | Length 27 in | In distribution |
| GP686-M | Length 18 in | In distribution |
| GC638-BRC | Length 27 in | In distribution |
| GC1635-M | Length 18 in | In distribution |
| GC1637-P | Length 18 in | In distribution |
| GC1654-BRC | Length 18 in | In distribution |
| GP612-M | Length 18 in | 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 |
| 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 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 30 |
Showing 12 of 237. All products under Suture, Absorbable, Natural
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982646 | 1999-06-02 |
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.