DemeSTEEL
Stainless Steel Surgical Non Absorbable Suture
1manufacturer
150catalogue numbers in this listing
1510(k) clearance
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 | Demetech Corp., United States |
|---|---|
| FDA product code | GAQ |
| Device type | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4495 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K141007 |
| Record published | 2019-07-11 |
| Record revised | 2025-09-26 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW2X110648B6P | In distribution | |
| SW4x110548B3P | In distribution | |
| SW5X110290B4P | In distribution | |
| SW210555B20P | In distribution | |
| SW4x110547B1P | In distribution | |
| SW4x115064B16P | In distribution | |
| SW4x110548B2P | In distribution | |
| SW110136B6P | In distribution | |
| SW4X110648B1P | In distribution | |
| SW4x110648B20P | In distribution | |
| SW110026B0P | In distribution | |
| SW110555B5P | In distribution | |
| SW6X110751B6P | In distribution | |
| SW4x110648B1P | In distribution | |
| SW3X2410650B2P | In distribution | |
| SW113019F4P | In distribution | |
| SW6x110748B4P | In distribution | |
| SW110548B2P | In distribution | |
| SW4X110748B1P | In distribution | |
| SW210245B1P | In distribution | |
| SW110448B2P | In distribution | |
| SW4x110547B6P | In distribution | |
| SW1120 | In distribution | |
| SW4x110448B20P | In distribution | |
| SW4x110245B20P | In distribution | |
| SW4x110745B2P | In distribution | |
| SW3X2410650B16P | In distribution | |
| SW210275G4P | In distribution | |
| SW4x110548B20P | In distribution | |
| SW4x110136B2P | In distribution | |
| SW4X110226B0P | In distribution | |
| SW2X110648B3P | In distribution | |
| SW2x110548B2P | In distribution | |
| SW17x1130 | In distribution | |
| SW1112045B0P | In distribution | |
| SW110748B6P | In distribution | |
| SW110140B4P | In distribution | |
| SW4X11050,4B6P | In distribution | |
| SW110245F4P | In distribution | |
| SW110126B0P | In distribution | |
| SW4X110548B6P | In distribution | |
| SW4x110440B1P | In distribution | |
| SW4X110547B20P | In distribution | |
| SW4x110548B0P | In distribution | |
| SW110140B6P | In distribution | |
| SW110750B20P | In distribution | |
| SW113036B4P | In distribution | |
| SW4x110240B2P | In distribution | |
| SW4x110445B2P | In distribution | |
| SW4x110140B4P | In distribution | |
| SW110648B4P | In distribution | |
| SW6107120B4P | In distribution | |
| SW2x210555B4P | In distribution | |
| SW11103 | In distribution | |
| SW5x110390B4P | In distribution | |
| SW210555B6P | In distribution | |
| SW4x110648B3P | In distribution | |
| SW4x116045B2P | In distribution | |
| SW2X114026F6P | In distribution | |
| SW4x110245F4P | In distribution | |
| SW210555B5P | In distribution | |
| SW4x110450B4P | In distribution | |
| SW110448B4P | In distribution | |
| SW6100 | In distribution | |
| SW4x110648B4P | In distribution | |
| SW4x110140B20P | In distribution | |
| SW4x110448B2P | In distribution | |
| SW2x210560B2P | In distribution | |
| SW910245F4P | In distribution | |
| SW4x210545B4P | In distribution | |
| SW4X110240B20P | In distribution | |
| SW11105 | In distribution | |
| SW4X110750B16P | In distribution | |
| SW112040F4P | In distribution | |
| SW1110548B4P | In distribution | |
| SW4X110248B6P | In distribution | |
| SW114019F4P | In distribution | |
| SW110650B20P | In distribution | |
| SW4x110448B4P | In distribution | |
| SW4x110648B6P | In distribution | |
| SW4x110647B6P | In distribution | |
| SW113024F4P | In distribution | |
| SW4x110140B6P | In distribution | |
| SW113030B0P | In distribution | |
| SW17x1100 | In distribution | |
| SW6x110648B4P | In distribution | |
| SW2X2414026F6P | In distribution | |
| SW4x110648B2P | In distribution | |
| SW4X110649B2P | In distribution | |
| SW4x110748B4P | In distribution | |
| SW4X110749B2P | In distribution | |
| SW4X110448B3P | In distribution | |
| SW8x112036B0P | In distribution | |
| SW4x114045B2P | In distribution | |
| SW4x117045B2P | In distribution | |
| SW2x110548B6P | In distribution | |
| SW212031B0P | In distribution | |
| SW2x110448B4P | In distribution | |
| SW4x110548B4P | In distribution | |
| SW4x210560B6P | In distribution | |
| SW110755B4P | In distribution | |
| SW4x110555B20P | In distribution | |
| SW4x110775B4P | In distribution | |
| SW4x110448B6P | In distribution | |
| SW4x110445B20P | In distribution | |
| SW8X2415060A4P | In distribution | |
| SW110648B6P | In distribution | |
| SW4x110148B20P | In distribution | |
| SW4X110448B0P | In distribution | |
| SW4x112040B2P | In distribution | |
| SW4x110748F4P | In distribution | |
| SW110660B6P | In distribution | |
| SW110427B0P | In distribution | |
| SW110748B4P | In distribution | |
| SW210555B4P | In distribution | |
| SW4x110148B6P | In distribution | |
| SW4x110748B2P | In distribution | |
| SW11104 | In distribution | |
| SW110445B6P | In distribution | |
| SW11101 | In distribution | |
| SW4x110048B20P | In distribution | |
| SW4x110555B4P | In distribution | |
| SW4X110136B20P | In distribution | |
| SW4X1105 | In distribution | |
| SW112030B0P | In distribution | |
| SW4x910245F4P | In distribution | |
| SW210555B0P | In distribution | |
| SW110240B4P | In distribution | |
| SW6x110548B4P | In distribution | |
| SW910140B6P | In distribution | |
| SW4x110645B2P | In distribution | |
| SW112036B0P | In distribution | |
| SW4x110564B16P | In distribution | |
| SW113030F4P | In distribution | |
| SW110548B6P | In distribution | |
| SW110540B4P | In distribution | |
| SW17x1120 | In distribution | |
| SW4x110750B4P | In distribution | |
| SW510140BI0P | In distribution | |
| SW4x110550B4P | In distribution | |
| SW213030B0P | In distribution | |
| SW4x110140B0P | In distribution | |
| SW110548B4P | In distribution | |
| SW8X115060A4P | In distribution | |
| SW4x110755B4P | In distribution | |
| SW4X110748B3P | In distribution | |
| SW12X1100 | In distribution | |
| SW4x110240B4P | In distribution | |
| SW4x110648B0P | In distribution | |
| SW110440B4P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ethibond Excel | Ethicon, Inc. | 175 |
| Deknatel | Teleflex Medical LLC | 94 |
| Ethicon | Ethicon, Inc. | 73 |
| Steel | Covidien LP | 44 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141007 | 2014-09-25 |
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.