DemeGUT
Chromic Gut, Sterile, Absorbable Surgical Suture
1manufacturer
1,421catalogue 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 | Demetech Corp., United States |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K072930 |
| Record published | 2023-09-25 |
| Record revised | 2024-03-22 (version 8) |
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 |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Pack of 12, pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP135012F4P | In distribution | |
| CP233035B0P | In distribution | |
| CC1020040B6 | In distribution | |
| CC2625020B0P | In distribution | |
| CC122035B0P | In distribution | |
| CC225023F2P | In distribution | |
| CC125012F4P | In distribution | |
| CP1030136B0P | In distribution | |
| CC1123019F13M | In distribution | |
| CC1723022F4P | In distribution | |
| CC1720145F0P | In distribution | |
| CC223026B26P | In distribution | |
| CC1020070B0 | In distribution | |
| CP1130126B0P | In distribution | |
| CC1020026B0P | In distribution | |
| CC1120120B0P | In distribution | |
| CC920136B0P | In distribution | |
| CP1133036B6P | In distribution | |
| CC1122037B4P | In distribution | |
| CC1125010G9P | In distribution | |
| CP230240B0P | In distribution | |
| CC225014B2P | In distribution | |
| CC1723026B0P | In distribution | |
| CC920040B0P | In distribution | |
| CC1124025B0P | In distribution | |
| CC220050B4P | In distribution | |
| CP1133036B4P | In distribution | |
| CC5204 | In distribution | |
| CC1120236B6P | In distribution | |
| CC1120127B0P | In distribution | |
| CC1120248B0P | In distribution | |
| CC1125019F13M | In distribution | |
| CC1120026B0P | In distribution | |
| CC1120131F0P | In distribution | |
| CC222048B0P | In distribution | |
| CC1124024B0P | In distribution | |
| CP233030F0P | In distribution | |
| CC1023017B0P | In distribution | |
| CC1122026B6P | In distribution | |
| CP230035B0P | In distribution | |
| CC220040H0P | In distribution | |
| CC220245B4P | In distribution | |
| CC226013F2P | In distribution | |
| CP230235B0P | In distribution | |
| CC125016B0P | In distribution | |
| CC1723022F2P | In distribution | |
| CP1132022F2P | In distribution | |
| CC222030B4P | In distribution | |
| CC220040B0P | In distribution | |
| CC320150B1P | In distribution | |
| CC1022030B4P | In distribution | |
| CC12600,8F14P | In distribution | |
| CP1133026B6P | In distribution | |
| CC225016B4P | In distribution | |
| CC520248B0P | In distribution | |
| CC120136B0P | In distribution | |
| CP232026B0P | In distribution | |
| CC220150B4P | In distribution | |
| CC221026F4P | In distribution | |
| CC1124035B0P | In distribution | |
| CP1732030B0P | In distribution | |
| CP135018B4P | In distribution | |
| CC1124017B12P | In distribution | |
| CC1020148F4P | In distribution | |
| CP135016F13M | In distribution | |
| CP136011F4P | In distribution | |
| CP1133024F13M | In distribution | |
| CP234021F2P | In distribution | |
| CC1024019F4P | In distribution | |
| CC1020148B0P | In distribution | |
| CC4200 | In distribution | |
| CC223048B0P | In distribution | |
| CC220243B0P | In distribution | |
| CP135012B0P | In distribution | |
| CP133026F4P | In distribution | |
| CC1122036H0P | In distribution | |
| CC1020140B0P | In distribution | |
| CP5320 | In distribution | |
| CC1122036B6P | In distribution | |
| CC1725016F0P | In distribution | |
| CC1120036B6P | In distribution | |
| CC125013F4P | In distribution | |
| CC825013G4P | In distribution | |
| CC220045B2P | In distribution | |
| CC1124016B0P | In distribution | |
| CP135010F2P | In distribution | |
| CC1120024F2P | In distribution | |
| CC1120036H0P | In distribution | |
| CC224020B0P | In distribution | |
| CC220126B1P | In distribution | |
| CC1020248B0P | In distribution | |
| CP232026F4P | In distribution | |
| CC12600,8G13M | In distribution | |
| CP134010B0P | In distribution | |
| CP1032030F4P | In distribution | |
| CC220130F2P | In distribution | |
| CC825013F4P | In distribution | |
| CP16330 | In distribution | |
| CC223025H4P | In distribution | |
| CP136013F13M | In distribution | |
| CC223022F4P | In distribution | |
| CP135010B0P | In distribution | |
| CC122022B2P | In distribution | |
| CC220240F4P | In distribution | |
| CC225024F4P | In distribution | |
| CC124013F13M | In distribution | |
| CC222035B6P | In distribution | |
| CC1023024F4P | In distribution | |
| CC220225B0P | In distribution | |
| CC225016F2P | In distribution | |
| CC220165B0P | In distribution | |
| CP234017F4P | In distribution | |
| CC1123040B0P | In distribution | |
| CP234016B2P | In distribution | |
| CP136013F0P | In distribution | |
| CC1023026B0P | In distribution | |
| CC223038B2P | In distribution | |
| CP231026F4P | In distribution | |
| CC220065F0P | In distribution | |
| CC223026B1P | In distribution | |
| CC920140B0P | In distribution | |
| CC220185B0P | In distribution | |
| CC1022035B0P | In distribution | |
| CC220136F0P | In distribution | |
| CC224024F2P | In distribution | |
| CC125013G4P | In distribution | |
| CP133018F4P | In distribution | |
| CC1020037B0 | In distribution | |
| CC222026B1P | In distribution | |
| CP1134017B0P | In distribution | |
| CC225015F4P | In distribution | |
| CP1134036B0P | In distribution | |
| CC124019F13M | In distribution | |
| CP1033030B0P | In distribution | |
| CC220236B0P | In distribution | |
| CC223030B6P | In distribution | |
| CC8x120131B1QR | In distribution | |
| CC1120220B4P | In distribution | |
| CP135016B13M | In distribution | |
| CC1622040C0P | In distribution | |
| CP230036B6P | In distribution | |
| CC220145B3P | In distribution | |
| CP1132035B4P | In distribution | |
| CC224017B4P | In distribution | |
| CC1020065B16P | In distribution | |
| CP134036B4P | In distribution | |
| CC1123020B0P | In distribution | |
| CC1020140B6P | In distribution | |
| CC225020F2P | In distribution | |
| CC1020140F4P | In distribution | |
| CC222050B0P | In distribution | |
| CC222036H0P | In distribution | |
| CC1120248B4P | In distribution | |
| CC223016B0P | In distribution | |
| CC624013B2P | In distribution | |
| CC221040B1P | In distribution | |
| CP233025B4P | In distribution | |
| CC224018F0P | In distribution | |
| CP530350B0P | In distribution | |
| CC1020026G4 | In distribution | |
| CP232022B0P | In distribution | |
| CP1133024F4P | In distribution | |
| CP233017B4P | In distribution | |
| CC125016B4P | In distribution | |
| CC1124015B0P | In distribution | |
| CC224016B18P | In distribution | |
| CC1023036B0P | In distribution | |
| CP230036B0P | In distribution | |
| CC226012B0P | In distribution | |
| CC16220 | In distribution | |
| CP230250B0P | In distribution | |
| CC220250B4P | In distribution | |
| CC225021B0P | In distribution | |
| CC1022030F4P | In distribution | |
| CC123030B0P | In distribution | |
| CC220136B4P | In distribution | |
| CC220035B4P | In distribution | |
| CC320265B0P | In distribution | |
| CC920030B0P | In distribution | |
| CC1020065B0 | In distribution | |
| CC1120230B4P | In distribution | |
| CC1622036C04P | In distribution | |
| CP1130030F0P | In distribution | |
| CC1123016F4P | In distribution | |
| CP1733040B0P | In distribution | |
| CC224025B0P | In distribution | |
| CP233030B0P | In distribution | |
| CC223022B1P | In distribution | |
| CC1022030B0P | In distribution | |
| CC1122031B4P | In distribution | |
| CC222055A2P | In distribution | |
| CC1123020B2P | In distribution | |
| CC225024B0P | In distribution | |
| CC220036B6P | In distribution | |
| CC1020048B6 | In distribution | |
| CC224019B4P | In distribution | |
| CC220035H4P | In distribution | |
| CC220036B0P | In distribution | |
| CC126011G4P | In distribution | |
| CC222037B2P | In distribution | |
| CP235016F2P | In distribution | |
| CC1123025B0P | In distribution | |
| CC1122025B0P | In distribution | |
| CP230026B0P | In distribution | |
| CC220040F2P | In distribution | |
| CC221026B0P | In distribution | |
| CC1023027B0P | In distribution | |
| CP134019F4P | In distribution | |
| CC220030F2P | In distribution | |
| CC222037B1P | In distribution | |
| CC223013F13M | In distribution | |
| CC126011G13M | In distribution | |
| CC223016B2P | In distribution | |
| CC223025B4P | In distribution | |
| CP1132024F4P | In distribution | |
| CP1035017B0P | In distribution | |
| CP233037B0P | In distribution | |
| CC220245B0P | In distribution | |
| CC220236B20P | In distribution | |
| CP234025B0P | In distribution | |
| CC1722030B0P | In distribution | |
| CC220123B4P | In distribution | |
| CC223060A4P | In distribution | |
| CC2202 | In distribution | |
| CC222022B0P | In distribution | |
| CP1034019F4P | In distribution | |
| CC5220 | In distribution | |
| CP230030B0P | In distribution | |
| CC123016B4P | In distribution | |
| CC1723020B0P | In distribution | |
| CP1034019B0P | In distribution | |
| CP233040B6P | In distribution | |
| CC223055A4P | In distribution | |
| CP1133025F6P | In distribution | |
| CC1124026B6P | In distribution | |
| CP1132040B0P | In distribution | |
| CP1032040B0P | In distribution | |
| CC1020230B0P | In distribution | |
| CP1032048B0P | In distribution | |
| CC220048B0P | In distribution | |
| CP1133026B0P | In distribution | |
| CC222024F4P | In distribution | |
| CP1132036B6P | In distribution | |
| CC125017F4P | In distribution | |
| CC220250B1P | In distribution | |
| CP232065B0P | In distribution | |
| CC1120236B0P | In distribution | |
| CP13600,65G7P | In distribution | |
| CC224036B0P | In distribution | |
| CC1122031F0P | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K072930 | 2008-04-30 |
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.