Ethi-PAK
Stainless Steel, Nonabsorbable Surgical Suture
1manufacturer
11catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
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 | Ethicon, Inc., 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, Specification developer, Manufacturer, Exporter |
| 510(k) | K931271 |
| Record published | 2015-09-01 |
| Record revised | 2026-03-27 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DS18 | 12 | In distribution | |
| DS22 | 12 | In distribution | |
| DS30 | 50 | In distribution | |
| DS25 | 12 | In distribution | |
| DS28 | 50 | In distribution | |
| DS26 | 50 | In distribution | |
| DS35 | 50 | In distribution | |
| DS24 | 12 | In distribution | |
| DS32 | 50 | In distribution | |
| DS20 | 12 | In distribution | |
| DS23 | 12 | In distribution |
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 |
| Steel | Covidien LP | 44 |
| Acier | Peters Surgical | 43 |
| E-Pack | Ethicon, Inc. | 17 |
| 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 |
|---|---|
| K170767 | 2017-11-01 |
| K946173 | 1995-01-09 |
| K931271 | 1994-01-07 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
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.