Ethibond Excel
Braided Polybutilate Coated Polyester, Synthetic Non-Absorbable Surgical Suture
6manufacturers in China registered for this device type
383catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2026-04-13 (version 11) |
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 | Special storage condition: Do not use if package is opened or damaged. |
| Packaging | Box of 36, box of 12, box of 6, box of 24 |
| Sizes | Length 60 to 75 cm; length 24 to 30 in |
| Distribution end date | 2023-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D10070 | In distribution | |
| D9128 | In distribution | |
| D8290 | In distribution | |
| D10071 | In distribution | |
| D7371 | In distribution | |
| X834H | In distribution | |
| D9822 | In distribution | |
| D6166 | In distribution | |
| CX74T | In distribution | |
| X6761G | In distribution | |
| D9607N | In distribution | |
| D9821 | In distribution | |
| X7056H | In distribution | |
| PXX86 | In distribution | |
| D5153 | In distribution | |
| DC423N | In distribution | |
| X562H | In distribution | |
| 10X72N | In distribution | |
| SXP76 | In distribution | |
| X917H | In distribution | |
| SXX54N | In distribution | |
| PX514 | In distribution | |
| X190G | In distribution | |
| D8318 | In distribution | |
| CX27D | In distribution | |
| D7091 | In distribution | |
| X976H | In distribution | |
| D8416 | In distribution | |
| X32201H | In distribution | |
| D7581 | In distribution | |
| D7435 | Length 75 cm | In distribution |
| B499T | In distribution | |
| PXX77FN | In distribution | |
| MX553 | In distribution | |
| X964H | In distribution | |
| PXX50N | In distribution | |
| D7716 | In distribution | |
| D9026 | In distribution | |
| X762H | In distribution | |
| CX46D | In distribution | |
| MPX37 | In distribution | |
| DC406N | In distribution | |
| D5286N | In distribution | |
| D9562 | In distribution | |
| D5977 | In distribution | |
| X204H | In distribution | |
| D8940N | In distribution | |
| X663H | In distribution | |
| D7083 | In distribution | |
| SXP52N | In distribution | |
| X32049H | In distribution | |
| D8685 | In distribution | |
| X32058H | In distribution | |
| D9656 | In distribution | |
| X905G | In distribution | |
| MX823 | In distribution | |
| D8811 | In distribution | |
| X4B37G | In distribution | |
| X761H | In distribution | |
| D9974N | In distribution | |
| D9263 | In distribution | |
| D9885N | In distribution | |
| D6584 | In distribution | |
| CX22D | In distribution | |
| D8492 | In distribution | |
| PX54H | In distribution | |
| X551H | In distribution | |
| X942H | In distribution | |
| PX977H | In distribution | |
| X7733H | In distribution | |
| D8253 | In distribution | |
| X7418H | In distribution | |
| D10048N | In distribution | |
| X997G | In distribution | |
| D10048 | In distribution | |
| D9504 | In distribution | |
| X890H | In distribution | |
| D10129 | In distribution | |
| SX17H | In distribution | |
| PX977 | In distribution | |
| EH7687H | In distribution | |
| PE6680H | In distribution | |
| D7924N | In distribution | |
| SXP77N | In distribution | |
| PXX52 | In distribution | |
| X305H | In distribution | |
| 10X82N | In distribution | |
| X6757G | In distribution | |
| EH7679H | In distribution | |
| EH7755H | In distribution | |
| X437H | In distribution | |
| X622H | In distribution | |
| CX14D | In distribution | |
| EH7713LG | In distribution | |
| DC573 | In distribution | |
| D9570 | In distribution | |
| PXX22N | In distribution | |
| D8634 | In distribution | |
| D8943 | In distribution | |
| X937H | In distribution | |
| SXX53 | In distribution | |
| 10X82 | In distribution | |
| W975G | In distribution | |
| 10X52N | In distribution | |
| D5150 | In distribution | |
| D5101 | In distribution | |
| 10X66N | In distribution | |
| D9975 | In distribution | |
| X695G | In distribution | |
| D8942 | In distribution | |
| X32047H | In distribution | |
| PXX85 | In distribution | |
| W979G | In distribution | |
| X411H | In distribution | |
| EB4407H | In distribution | |
| D5169 | In distribution | |
| D6864 | In distribution | |
| X833H | In distribution | |
| PXX50 | In distribution | |
| X496T | In distribution | |
| MX552 | In distribution | |
| DC659 | In distribution | |
| X925H | In distribution | |
| 6965H | In distribution | |
| X843H | In distribution | |
| D6940 | In distribution | |
| X936H | In distribution | |
| PXX77 | In distribution | |
| X424H | In distribution | |
| PX83H | In distribution | |
| X185H | In distribution | |
| MX944 | In distribution | |
| D7576N | In distribution | |
| X7723H | In distribution | |
| SXP82 | In distribution | |
| D8944 | In distribution | |
| D9260 | In distribution | |
| D5794 | In distribution | |
| D9185 | In distribution | |
| X966H | In distribution | |
| X558H | In distribution | |
| X7909H | In distribution | |
| X412H | In distribution | |
| PXX87 | In distribution | |
| X844H | In distribution | |
| D9249N | In distribution | |
| X406T | In distribution | |
| D9329N | In distribution | |
| DC277 | In distribution | |
| D9977 | In distribution | |
| PXX79N | In distribution | |
| D5570 | In distribution | |
| D8868 | In distribution | |
| DC472 | In distribution | |
| D10068 | In distribution | |
| D9913 | In distribution | |
| D10067 | In distribution | |
| X807H | In distribution | |
| X872H | In distribution | |
| D9999 | In distribution | |
| D9420 | In distribution | |
| PX1007N | In distribution | |
| D6598 | In distribution | |
| X556H | In distribution | |
| D10071N | In distribution | |
| D7581N | In distribution | |
| D8302 | In distribution | |
| X881H | In distribution | |
| D8737 | In distribution | |
| D8922 | In distribution | |
| D6802 | In distribution | |
| DC552 | In distribution | |
| X884G | In distribution | |
| PX514G | In distribution | |
| X870H | In distribution | |
| SX54H | In distribution | |
| MX927 | In distribution | |
| X7497H | In distribution | |
| PXX82 | In distribution | |
| X864H | In distribution | |
| X6891G | In distribution | |
| X434H | In distribution | |
| X6805H | In distribution | |
| PX65H | In distribution | |
| D8366 | In distribution | |
| D8527N | In distribution | |
| PX937H | In distribution | |
| D9626 | In distribution | |
| D9249 | In distribution | |
| X31011H | In distribution | |
| DC493 | In distribution | |
| D9301 | In distribution | |
| X306H | In distribution | |
| D5864 | In distribution | |
| SXP07H | In distribution | |
| D4973 | In distribution | |
| SXP02H | In distribution | |
| CX30D | In distribution | |
| EH7717LG | In distribution | |
| D9327 | In distribution | |
| CX21D | In distribution | |
| X4843G | In distribution | |
| D5834 | In distribution | |
| SXP77 | In distribution | |
| D8511 | In distribution | |
| D10099 | In distribution | |
| X7479G | In distribution | |
| D7976 | In distribution | |
| D7390N | In distribution | |
| SXP52 | In distribution | |
| 10X42N | In distribution | |
| SXP54N | In distribution | |
| EH7551H | In distribution | |
| X832H | In distribution | |
| D9670 | In distribution | |
| X32071H | In distribution | |
| E6194G | In distribution | |
| D6088 | In distribution | |
| D9458 | In distribution | |
| X31043H | In distribution | |
| CX75T | In distribution | |
| PXX43 | In distribution | |
| X444H | In distribution | |
| 10X53N | In distribution | |
| D9306 | In distribution | |
| SXX50N | In distribution | |
| PXX87N | In distribution | |
| D6341 | In distribution | |
| D7288 | In distribution | |
| D8523 | In distribution | |
| D8107 | In distribution | |
| D9238 | In distribution | |
| D5844N | In distribution | |
| X32200H | In distribution | |
| D9079N | In distribution | |
| X303H | In distribution | |
| X6977M | In distribution | |
| X32019H | In distribution | |
| SXX43 | In distribution | |
| X4B77G | In distribution | |
| PXX76 | In distribution | |
| PXX22 | In distribution | |
| EH7673H | In distribution | |
| D9522 | In distribution | |
| PXX76N | In distribution | |
| MB47G | In distribution | |
| D7341 | Length 30 in | In distribution |
| D7931N | In distribution | |
| D7129N | In distribution | |
| EH7573H | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
| HyperSuture | Threadstone LLC | 137 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon Endo-Surgery, Inc. | UDI-DI | 2025-03-07 | Class II | Process control | Identified curing issues with the silicone during the needles manufacturing process. | 2,556 units | |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 1296 eaches | 2021-02-05 |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 36 eaches | 2021-02-05 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, 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.