Steel
Monofilament Stainless Steel,HOS-14,(7),7x Strands
1manufacturer
44catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAQ |
| Device type | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4495 |
| 510(k) | K955723 |
| Record published | 2015-08-31 |
| Record revised | 2025-06-24 (version 14) |
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 12, case of 36 |
| Sizes | Length 18 to 30 in |
| Distribution end date | 2026-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88862228-89 | Length 30 in | In distribution |
| 88862495-89 | Length 18 in | In distribution |
| 88862407-53 | Length 18 in | In distribution |
| 88862222-89 | diameter,5,N/A; | In distribution |
| 88862497-89 | Length 30 in | In distribution |
| 88862410-69 | Length 18 in | In distribution |
| 88862408-73 | Length 18 in | In distribution |
| 88862407-43 | Length 18 in | In distribution |
| 88862226-69 | Length 18 in | In distribution |
| 88862393-89 | Length 18 in | In distribution |
| 88862226-89 | Length 18 in | In distribution |
| 88862494-89 | Length 30 in | In distribution |
| 88862414-89 | diameter,5,N/A; | In distribution |
| 88862345-53 | Length 18 in | In distribution |
| 88862408-83 | Length 18 in | In distribution |
| 88862424-89 | Length 30 in | In distribution |
| 88862224-69 | Length 18 in | In distribution |
| 88862222-69 | Length 18 in | In distribution |
| 88862410-89 | Length 18 in | In distribution |
| 88862382-83 | Length 18 in | In distribution |
| 88862407-49 | Length 18 in | In distribution |
| 88862407-63 | Length 18 in | In distribution |
| 88862392-49 | Length 18 in | In distribution |
| 88862420-09 | diameter,4,N/A; | In distribution |
| 88862412-89 | Length 30 in | In distribution |
| 88862224-09 | Length 18 in | In distribution |
| 88862420-83 | Length 18 in | In distribution |
| 88862396-89 | Length 30 in | In distribution |
| 88862224-49 | Length 18 in | In distribution |
| 88862392-69 | Length 18 in | In distribution |
| 88862224-89 | Length 18 in | In distribution |
| 88862393-69 | Length 18 in | In distribution |
| 88862413-83 | Length 18 in | In distribution |
| 88862466-25 | Length 18 in | In distribution |
| 88862348-53 | Length 24 in | Withdrawn |
| W-497G | Length 20 in | Withdrawn |
| XX-2125 | Length 18 in | Withdrawn |
| 88862376-89 | diameter,5,N/A; | Withdrawn |
| 88862431-41 | Length 20 in | Withdrawn |
| W-20G | diameter,5,N/A; | Withdrawn |
| W-618G | Length 18 in | Withdrawn |
| VW-651-M | Length 18 in | Withdrawn |
| W-23G | Length 18 in | Withdrawn |
| W-22G | Length 18 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ethibond Excel | Ethicon, Inc. | 175 |
| DemeSTEEL | Demetech Corp. | 150 |
| Deknatel | Teleflex Medical LLC | 94 |
| Ethicon | Ethicon, Inc. | 73 |
| Acier | Peters Surgical | 43 |
| E-Pack | Ethicon, Inc. | 17 |
| Ethi-PAK | Ethicon, Inc. | 11 |
| Steel Wire | Resorba Medical GmbH | 10 |
| Steelex | B Braun Surgical SA | 7 |
| Valkyrie | Surgical Specialties México, S. de R.L. de C.V. | 6 |
| Fumedica | Surgical Specialties México, S. de R.L. de C.V. | 6 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | Synthes Gmbh | 6 |
Showing 12 of 26. All products under Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Recalls Naming This Product
1 recall names this product by its own identifier, 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 |
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.