Endure Industries
Endure Sutures NYLON Blue, 60mm, Straight Cutting, 75cm, 2-0
6manufacturers in China registered for this device type
59catalogue 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 | Endure Industries, Inc., United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130735 |
| Record published | 2023-10-15 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 49 °C; Handling environment temperature 0 to 49 °C |
| Packaging | Box of 12, case of 1200, box, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EA4-45X6 | In distribution | |
| EG36193U-75 | In distribution | |
| EG46133U-45 | In distribution | |
| D229442 | In distribution | |
| EG5F133U-45 | In distribution | |
| EG36263U-45 | In distribution | |
| EG46193U-45 | In distribution | |
| EG2F363U-75 | In distribution | |
| ED21262-75 | In distribution | |
| EG31262U-70 | In distribution | |
| EG56133U-45 | In distribution | |
| EK46193-75 | In distribution | |
| EA26263U-75 | In distribution | |
| D101391 | In distribution | |
| EA46163U-75 | In distribution | |
| EN66133-60 | In distribution | |
| EN56133-45 | In distribution | |
| EA56133U-45 | In distribution | |
| EN56163-45 | In distribution | |
| ED56133-45 | In distribution | |
| ED56163-75 | In distribution | |
| EG56163U-45 | In distribution | |
| EA66133U-45 | In distribution | |
| EK56133-45 | In distribution | |
| EG36193U-45 | In distribution | |
| EN46163-75 | In distribution | |
| EJ43130-45 | In distribution | |
| EA56163U-45 | In distribution | |
| EN46193-75 | In distribution | |
| EN56133-60 | In distribution | |
| EG56193U-75 | In distribution | |
| EN56163-60 | In distribution | |
| EA26303U-75 | In distribution | |
| EK36193-75 | In distribution | |
| EG46163U-45 | In distribution | |
| EG36263U-75 | In distribution | |
| EG56193U-45 | In distribution | |
| EN36243-75 | In distribution | |
| EN23600-75 | In distribution | |
| EN36243-45 | In distribution | |
| EA3-45X6 | In distribution | |
| D101391 | In distribution | |
| EN46163-45 | In distribution | |
| EG66113U-45 | In distribution | |
| EG21312-75 | In distribution | |
| ED46163-75 | In distribution | |
| EA46163U-45 | In distribution | |
| ED56163-45 | In distribution | |
| ED36193-75 | In distribution | |
| EN66133-45 | In distribution | |
| EA36193U-45 | In distribution | |
| EK36263-75 | In distribution | |
| ED46193-75 | In distribution | |
| ED46163-45 | In distribution | |
| EN46133-45 | In distribution | |
| EG66133U-45 | In distribution | |
| EN46133-75 | In distribution | |
| EG61132U-45 | In distribution | |
| EK46133-75 | In distribution |
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 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| 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 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
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.