Ti-Cron
Coated Braided Polyester, CV-305, D/A, 4Blue/4White Strands with Soft PTFE Pledget 3x6x1.65
6manufacturers in China registered for this device type
482catalogue 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 | Covidien LP, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| 510(k) | K930591 |
| Record published | 2015-09-02 |
| Record revised | 2026-04-13 (version 17) |
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 | Handling environment temperature up to 130 °F |
| Packaging | Case of 36, case of 6, case of 24, case of 12, pack_or_inner_pack of 6, pack_or_inner_pack of 36 |
| Sizes | Length 12 to 100 in |
| Distribution end date | 2025-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X-1216 | diameter,2/0,N/A; | In distribution |
| 88863023-71 | diameter,1,N/A; | In distribution |
| 88863372-82 | Length 18 in | In distribution |
| 88863380-52 | diameter,2/0,N/A; | In distribution |
| 88863035-41 | diameter,3/0,N/A; | In distribution |
| 88863045-21 | diameter,5/0,N/A; | In distribution |
| XX-2150 | Length 36 in | In distribution |
| 88863083-56 | Length 30 in | In distribution |
| 88863147-83 | diameter,2,N/A; | In distribution |
| 88863261-62 | Length 18 in | In distribution |
| 88863062-61 | diameter,0,N/A; | In distribution |
| 88863003-42 | Length 30 in | In distribution |
| 88863185-71 | diameter,1,N/A; | In distribution |
| 88863374-62 | diameter,0,N/A; | In distribution |
| VCD8051G | Length 30 in | In distribution |
| 88863111-79 | diameter,5,N/A; | In distribution |
| 88862815-51 | Length 36 in | In distribution |
| 88863054-81 | Length 30 in | In distribution |
| 88863191-51 | diameter,2/0,N/A; | In distribution |
| XX-5132 | diameter,4/0,N/A; | In distribution |
| 8886310421-2 | diameter,5/0,N/A; | In distribution |
| 88863259-62 | Length 18 in | In distribution |
| VCD20305SE | Diameter, 2/0, N/A; | In distribution |
| SCD-3058G | diameter,5/0,N/A; | In distribution |
| 88863226-31 | Length 24 in | In distribution |
| 88863160-41 | Length 36 in | In distribution |
| 88862851-56 | Length 36 in | In distribution |
| XX-5235 | diameter,3/0,N/A; | In distribution |
| VCD8011G | Diameter, 6/0, N/A; | In distribution |
| 88863213-66 | diameter,0,N/A; | In distribution |
| 88863092-61 | Length 30 in | In distribution |
| 88863185-31 | diameter,4/0,N/A; | In distribution |
| VCD2030556MSE | Diameter, 2/0, N/A; | In distribution |
| 88862839-51 | diameter,2/0,N/A; | In distribution |
| 88863163-51 | diameter,2/0,N/A; | In distribution |
| 88863146-81 | diameter,2,N/A; | In distribution |
| 88863103-71 | diameter,1,N/A; | In distribution |
| 88862862-34 | diameter,4/0,N/A; | In distribution |
| 88863113-81 | diameter,2,N/A; | In distribution |
| 88863159-31 | diameter,4/0,N/A; | In distribution |
| 88862811-51 | Length 36 in | In distribution |
| 88863227-41 | Length 30 in | In distribution |
| 88863230-56 | Length 36 in | In distribution |
| 88863117-61 | diameter,0,N/A; | In distribution |
| 88863155-81 | Length 30 in | In distribution |
| SCD-3059G | Length 18 in | In distribution |
| 88863240-56 | diameter,2/0,N/A; | In distribution |
| 88863157-51 | Length 36 in | In distribution |
| 88863226-41 | diameter,3/0,N/A; | In distribution |
| 88863323-56 | Length 30 in | In distribution |
| 88863211-56 | Length 30 in | In distribution |
| 88863054-61 | diameter,0,N/A; | In distribution |
| 88863290-56 | Length 36 in | In distribution |
| 88863205-41 | diameter,3/0,N/A; | In distribution |
| 88863260-62 | diameter,0,N/A; | In distribution |
| 88863306-56 | Length 36 in | In distribution |
| 88863274-61 | Length 30 in | In distribution |
| VCD-375 | Length 30 in | In distribution |
| 88863275-56 | Length 36 in | In distribution |
| 88863003-52 | Length 30 in | In distribution |
| X-1162 | Length 30 in | In distribution |
| VCD20316FE | Diameter, 2/0, N/A; | In distribution |
| 88863011-51 | Length 18 in | In distribution |
| 88863369-51 | diameter,2/0,N/A; | In distribution |
| 88863222-56 | diameter,2/0,N/A; | In distribution |
| 88863309-71 | Length 30 in | In distribution |
| 88863235-56 | diameter,2/0,N/A; | In distribution |
| XX-5194J | Length 18 in | In distribution |
| 88863228-56 | diameter,2/0,N/A; | In distribution |
| 88862978-51 | Length 30 in | In distribution |
| 88863107-31 | diameter,4/0,N/A; | In distribution |
| 88863297-21 | Length 36 in | In distribution |
| 88863280-11 | diameter,6/0,N/A; | In distribution |
| 88863303-56 | diameter,2/0,N/A; | In distribution |
| 88863386-62 | diameter,0,N/A; | In distribution |
| 88863190-61 | diameter,0,N/A; | In distribution |
| XX-5115 | Length 30 in | In distribution |
| 88863056-89 | diameter,5,N/A; | In distribution |
| X-1104 | Length 36 in | In distribution |
| 88863255-56 | Length 36 in | In distribution |
| 88863090-51 | Length 30 in | In distribution |
| 88862808-51 | Length 36 in | In distribution |
| 88863147-89 | diameter,5,N/A; | In distribution |
| 88863267-42 | diameter,3/0,N/A; | In distribution |
| 88863229-41 | Length 30 in | In distribution |
| 88863256-31 | Length 36 in | In distribution |
| 88863163-61 | diameter,0,N/A; | In distribution |
| 88863220-56 | diameter,2/0,N/A; | In distribution |
| 88863218-56 | Length 30 in | In distribution |
| 88863307-56 | diameter,2/0,N/A; | In distribution |
| CD-0423K | diameter,5/0,N/A; | In distribution |
| 88863280-31 | diameter,4/0,N/A; | In distribution |
| 88863393-61 | Length 36 in | In distribution |
| 88863381-89 | Length 60 in | In distribution |
| VCD-320 | diameter,3/0,N/A; | In distribution |
| 88863128-79 | diameter,5,N/A; | In distribution |
| 88862962-83 | Length 30 in | In distribution |
| VCD-656 | diameter,2/0,N/A; | In distribution |
| 88863395-71 | diameter,1,N/A; | In distribution |
| 88863261-82 | Length 18 in | In distribution |
| VCD2203 | Length 36 in | In distribution |
| 88862801-21 | Length 30 in | In distribution |
| 88862947-53 | Length 30 in | In distribution |
| VCD-110 | diameter,2/0,N/A; | In distribution |
| 88863256-51 | Length 36 in | In distribution |
| SCD-2864G | diameter,5/0,N/A; | In distribution |
| X-1146 | diameter,3/0,N/A; | In distribution |
| 88863037-56 | diameter,2/0,N/A; | In distribution |
| XX-5058 | diameter,2/0,N/A; | In distribution |
| 88863375-71 | diameter,1,N/A; | In distribution |
| 88863052-56 | Length 36 in | In distribution |
| 88863395-51 | Length 30 in | In distribution |
| 88863160-31 | Length 36 in | In distribution |
| 88863269-56 | Length 36 in | In distribution |
| X1391 | Length 36 in | In distribution |
| X-1181 | diameter,3/0,N/A; | In distribution |
| 88862854-33 | diameter,4/0,N/A; | In distribution |
| 88863113-71 | Length 30 in | In distribution |
| 88863257-62 | Length 18 in | In distribution |
| 88863185-41 | Length 30 in | In distribution |
| 88863324-56 | Length 30 in | In distribution |
| 88863001-41 | Length 18 in | In distribution |
| 88863097-71 | diameter,1,N/A; | In distribution |
| 88863380-42 | diameter,3/0,N/A; | In distribution |
| 88863026-71 | Length 30 in | In distribution |
| 88863380-62 | diameter,0,N/A; | In distribution |
| 88863059-53 | diameter,2/0,N/A; | In distribution |
| 88863082-61 | diameter,0,N/A; | In distribution |
| 88863084-56 | Length 30 in | In distribution |
| 88863353-56 | diameter,2/0,N/A; | In distribution |
| 88863182-31 | diameter,4/0,N/A; | In distribution |
| 88863309-61 | Length 30 in | In distribution |
| XX-5126 | diameter,5/0,N/A; | In distribution |
| SCD-3049G | Length 18 in | In distribution |
| 88863090-81 | Length 30 in | In distribution |
| 88863027-79 | Length 30 in | In distribution |
| 88862877-56 | diameter,2/0,N/A; | In distribution |
| XX-5056 | diameter,4/0,N/A; | In distribution |
| 88863261-72 | diameter,1,N/A; | In distribution |
| 88863393-51 | Length 36 in | In distribution |
| 88863203-56 | Length 30 in | In distribution |
| 88863380-82 | diameter,2,N/A; | In distribution |
| 88863127-79 | diameter,5,N/A; | In distribution |
| 88862880-51 | diameter,2/0,N/A; | In distribution |
| 88863023-51 | diameter,2/0,N/A; | In distribution |
| 88863023-61 | Length 30 in | In distribution |
| 88863008-21 | Length 18 in | In distribution |
| 88863012-61 | Length 36 in | In distribution |
| 88863344-56 | diameter,2/0,N/A; | In distribution |
| 88863298-21 | Length 30 in | In distribution |
| 88863117-71 | diameter,1,N/A; | In distribution |
| 88863167-51 | Length 36 in | In distribution |
| 88863324-66 | Length 30 in | In distribution |
| VCD2030556MFE | Length 30 in | In distribution |
| 88863088-51 | Length 30 in | In distribution |
| 88863062-41 | diameter,3/0,N/A; | In distribution |
| 88863086-56 | Length 30 in | In distribution |
| 88863167-41 | Length 36 in | In distribution |
| 88863226-21 | diameter,5/0,N/A; | In distribution |
| 88863221-56 | diameter,2/0,N/A; | In distribution |
| 88863154-09 | diameter,4,N/A; | In distribution |
| 88863008-51 | Length 18 in | In distribution |
| 88862914-61 | Length 36 in | In distribution |
| 88863204-51 | diameter,2/0,N/A; | In distribution |
| 88863277-56 | Length 30 in | In distribution |
| 88863370-51 | diameter,2/0,N/A; | In distribution |
| 88863205-51 | Length 30 in | In distribution |
| X-1136 | diameter,4/0,N/A; | In distribution |
| 88863069-41 | diameter,3/0,N/A; | In distribution |
| 88862840-51 | Length 36 in | In distribution |
| 88863093-61 | diameter,0,N/A; | In distribution |
| X-1137 | Length 30 in | In distribution |
| XX-5154 | Length 30 in | In distribution |
| 88863185-51 | diameter,2/0,N/A; | In distribution |
| 88863314-21 | diameter,5/0,N/A; | In distribution |
| 88863258-42 | Length 18 in | In distribution |
| 8886263656-2 | Length 36 in | In distribution |
| 88863046-31 | diameter,4/0,N/A; | In distribution |
| 88863202-51 | Length 30 in | In distribution |
| 88863028-71 | diameter,1,N/A; | In distribution |
| VCD20305MFE | Diameter, 2/0, N/A; | In distribution |
| 88863336-51 | Length 36 in | In distribution |
| X-1147 | diameter,3/0,N/A; | In distribution |
| 88863119-61 | Length 30 in | In distribution |
| 88863015-61 | diameter,0,N/A; | In distribution |
| 88863097-61 | Length 30 in | In distribution |
| XX-5027 | Length 30 in | In distribution |
| 88862658-56 | Length 36 in | In distribution |
| 88863385-56 | Length 30 in | In distribution |
| CD-3113K | diameter,6/0,N/A; | In distribution |
| 88862775-41 | Length 30 in | In distribution |
| 88863008-31 | Length 18 in | In distribution |
| 88863087-31 | Length 30 in | In distribution |
| CD-3123K | diameter,5/0,N/A; | In distribution |
| 88863002-62 | Length 30 in | In distribution |
| 88863256-61 | Length 36 in | In distribution |
| 88863193-51 | diameter,2/0,N/A; | In distribution |
| 88863008-41 | Length 18 in | In distribution |
| 88863087-51 | Length 30 in | In distribution |
| VCD20316MFE | Length 30 in | In distribution |
| 88863374-52 | Length 18 in | In distribution |
| 88863295-41 | diameter,3/0,N/A; | In distribution |
| 88863163-71 | diameter,1,N/A; | In distribution |
| 88863249-31 | Length 36 in | In distribution |
| 88863185-61 | diameter,0,N/A; | In distribution |
| 88863395-81 | diameter,2,N/A; | In distribution |
| 88863219-56 | Length 30 in | In distribution |
| 88863109-43 | Length 18 in | In distribution |
| 88863229-31 | Length 30 in | In distribution |
| XX-5129 | diameter,4/0,N/A; | In distribution |
| 88863258-32 | diameter,4/0,N/A; | In distribution |
| 88863309-51 | diameter,2/0,N/A; | In distribution |
| XX-5234 | Length 30 in | In distribution |
| 88863055-41 | diameter,3/0,N/A; | In distribution |
| 88863369-41 | Length 36 in | In distribution |
| 88863319-51 | diameter,2/0,N/A; | In distribution |
| 88863258-52 | Length 18 in | In distribution |
| XX-5226 | Length 30 in | In distribution |
| 88863048-51 | Length 30 in | In distribution |
| 88863227-51 | Length 30 in | In distribution |
| 88863381-09 | Length 60 in | In distribution |
| 88863380-72 | Length 100 in | In distribution |
| 88863356-56 | diameter,2/0,N/A; | In distribution |
| 88862775-31 | diameter,4/0,N/A; | In distribution |
| 88863065-51 | diameter,2/0,N/A; | In distribution |
| 88863186-51 | diameter,2/0,N/A; | In distribution |
| 88862981-56 | Length 36 in | In distribution |
| 88863182-41 | diameter,3/0,N/A; | In distribution |
| 88863348-51 | Length 30 in | In distribution |
| 88863212-51 | diameter,2/0,N/A; | In distribution |
| 88862768-51 | Length 30 in | In distribution |
| 88863139-21 | diameter,5/0,N/A; | In distribution |
| X-1220 | diameter,2/0,N/A; | In distribution |
| 88863241-56 | diameter,2/0,N/A; | In distribution |
| 88862775-21 | diameter,5/0,N/A; | In distribution |
| X-1218 | diameter,3/0,N/A; | In distribution |
| 88863379-52 | diameter,2/0,N/A; | In distribution |
| 88863314-31 | diameter,4/0,N/A; | In distribution |
| 88863033-52 | Length 30 in | In distribution |
| 88863239-51 | diameter,2/0,N/A; | In distribution |
| 88863369-31 | Length 36 in | In distribution |
| XX-5193J | Length 18 in | In distribution |
| 88863233-51 | Length 30 in | In distribution |
| XX-5172 | diameter,2/0,N/A; | In distribution |
| 88863236-56 | diameter,2/0,N/A; | In distribution |
| 88863062-51 | diameter,2/0,N/A; | In distribution |
| 88863003-32 | Length 30 in | In distribution |
| VCD20305FE | Diameter, 2/0, N/A; | In distribution |
| 88863054-71 | Length 30 in | In distribution |
| X-1159 | diameter,5/0,N/A; | 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 |
| 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 |
| HyperSuture | Threadstone LLC | 137 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2023-12-21 | Class II | Process control | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood | 46,812 US; 68,976 OUS |
| Covidien | UDI-DI | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 40152 units |
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.