E-Pack
17 catalogue numbers from 9719E, listed by Ethicon, Inc., United States, under Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile. 1 manufacturer in China is registered for this product code.
1manufacturer
17catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2017-12-06 |
| Record revised | 2025-07-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Away from moisture and direct heat; Storage environment temperature up to 77 °F; Storage environment temperature up to 25 °C |
| Packaging | Box of 5 |
| Distribution end date | 2019-08-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9719E | Withdrawn | |
| 7395E | Withdrawn | |
| 9834E | Withdrawn | |
| 9921E | Withdrawn | |
| 9833E | Withdrawn | |
| 7977E | Withdrawn | |
| 8124E | Withdrawn | |
| 9895E | Withdrawn | |
| 7438E | Withdrawn | |
| 9846E | Withdrawn | |
| 9700E | Withdrawn | |
| 9828E | Withdrawn | |
| 9807E | Withdrawn | |
| 9803E | Withdrawn | |
| 9885E | Withdrawn | |
| 9839E | Withdrawn | |
| 9808E | Withdrawn |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 |
| Steel | Covidien LP | 44 |
| Acier | Peters Surgical | 43 |
| 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 |
|---|---|
| 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.