Deknatel
Stainless Monofilament 5 HSCX60 1N 4X75 Centimeter
1manufacturer
94catalogue numbers in this listing
3recalls 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 | Teleflex Medical LLC, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-07-26 |
| Record revised | 2022-04-28 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: none |
| Packaging | Box of 12, sleeve, box of 6, box, sleeve of 12 |
| Sizes | Length 45 to 75 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN026958 | Length 45 cm | In distribution |
| IPN011619 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN049527 | Length 45 cm | In distribution |
| IPN004787 | STAINLESS STEEL /Needle HSCX48 Size-6 | In distribution |
| IPN004794 | Length 45 cm | In distribution |
| IPN049520 | STAINLESS STEEL /Needle K-60 Size-7 | In distribution |
| IPN049571 | STAINLESS STEEL /Needle KC-6 Size-0 | In distribution |
| IPN026956 | STAINLESS STEEL /Needle B-60, K-60 Size-7 | In distribution |
| IPN026898 | Length 45 cm | In distribution |
| IPN026841 | STAINLESS STEEL /Needle KC-2 Size-1 | In distribution |
| IPN026987 | Length 45 cm | In distribution |
| IPN004796 | Length 45 cm | In distribution |
| IPN029047 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN026941 | Length 45 cm | In distribution |
| IPN004797 | Length 45 cm | In distribution |
| IPN004789 | Length 45 cm | In distribution |
| IPN004790 | Length 45 cm | In distribution |
| IPN026898 | STAINLESS STEEL /Needle Size-1 | In distribution |
| IPN004800 | STAINLESS STEEL /Needle K-61 Size-4 | In distribution |
| IPN011611 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN004783 | STAINLESS STEEL /Needle HSCX60 Size-6 | In distribution |
| IPN004800 | Length 45 cm | In distribution |
| IPN004816 | Length 45 cm | In distribution |
| IPN004805 | Length 45 cm | In distribution |
| IPN026836 | Length 45 cm | In distribution |
| IPN029051 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN029170 | STAINLESS STEEL /Needle HSCX48 Size-7 | In distribution |
| IPN004805 | Length 45 cm | In distribution |
| IPN029048 | STERNOTOMY /Needle HSCX60 Size-5 | In distribution |
| IPN004793 | STAINLESS STEEL /Needle K-60 Size-6 | In distribution |
| IPN011617 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN004791 | STAINLESS STEEL /Needle K-60 Size-5 | In distribution |
| IPN026956 | STAINLESS STEEL /Needle B-60, K-60 Size-7 | In distribution |
| IPN004787 | STAINLESS STEEL /Needle HSCX48 Size-6 | In distribution |
| IPN026838 | Length 45 cm | In distribution |
| IPN026901 | STAINLESS STEEL /Needle Size-7 | In distribution |
| IPN029043 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN029166 | Length 45 cm | In distribution |
| IPN011624 | Length 45 cm | In distribution |
| IPN049522 | STAINLESS STEEL /Needle K-60 Size-6 | In distribution |
| IPN004782 | STAINLESS STEEL /Needle HSCX48 Size-7 | In distribution |
| IPN026933 | Length 45 cm | In distribution |
| IPN026805 | Length 45 cm | In distribution |
| IPN026941 | STAINLESS STEEL /Needle KC-6 Size-2 | In distribution |
| IPN004790 | STAINLESS STEEL /Needle K-60 Size-7 | In distribution |
| IPN026781 | STAINLESS STEEL /Needle K-60 Size-7 | In distribution |
| IPN049588 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN029045 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN011612 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN004809 | Length 45 cm | In distribution |
| IPN049590 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN027102 | STAINLESS STEEL /Needle C-2 Size-1 | In distribution |
| IPN004816 | STAINLESS STEEL /Needle K-60 Size-6 | In distribution |
| IPN004798 | Length 45 cm | In distribution |
| IPN026958 | STAINLESS STEEL /Needle B-60, K-60 Size-5 | In distribution |
| IPN011626 | Length 45 cm | In distribution |
| IPN029050 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN011627 | Length 75 cm | In distribution |
| IPN026841 | STAINLESS STEEL /Needle KC-2 Size-1 | In distribution |
| IPN049526 | Length 45 cm | In distribution |
| IPN011615 | Length 45 cm | In distribution |
| IPN049589 | STERNOTOMY /Needle K-60 Size-7 | In distribution |
| IPN011620 | Length 75 cm | In distribution |
| IPN026978 | STAINLESS STEEL /Needle C-2 Size-2 | In distribution |
| IPN004809 | Length 45 cm | In distribution |
| IPN026901 | Length 45 cm | In distribution |
| IPN026781 | Length 45 cm | In distribution |
| IPN004781 | STAINLESS STEEL /Needle HSCX48 Size-7 | In distribution |
| IPN011613 | Length 75 cm | In distribution |
| IPN049523 | Length 45 cm | In distribution |
| IPN049521 | STAINLESS STEEL /Needle K-60 Size-6 | In distribution |
| IPN026783 | Length 45 cm | In distribution |
| IPN004791 | Length 75 cm | In distribution |
| IPN029049 | STERNOTOMY /Needle K-60 Size-6 | In distribution |
| IPN049525 | STAINLESS STEEL /Needle K-60 Size-4 | In distribution |
| IPN049524 | STAINLESS STEEL /Needle K-60 Size-5 | In distribution |
| IPN026899 | STAINLESS STEEL /Needle Size-2 | In distribution |
| IPN026933 | Length 45 cm | In distribution |
| IPN026987 | Length 45 cm | In distribution |
| IPN026920 | Length 45 cm | In distribution |
| IPN026842 | STAINLESS STEEL /Needle KC-2 Size-1 | In distribution |
| IPN029167 | STAINLESS STEEL /Needle HSCX60 Size-6 | In distribution |
| IPN027102 | Length 45 cm | In distribution |
| IPN011623 | Length 45 cm | In distribution |
| IPN026836 | STAINLESS STEEL /Needle B-60 Size-5 | In distribution |
| IPN026842 | STAINLESS STEEL /Needle KC-2 Size-1 | In distribution |
| IPN026899 | Length 45 cm | In distribution |
| IPN029044 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN026920 | Length 45 cm | In distribution |
| IPN029046 | STERNOTOMY /Needle K-60 Size-5 | In distribution |
| IPN004792 | Length 45 cm | In distribution |
| IPN026838 | Length 45 cm | In distribution |
| IPN011618 | Length 45 cm | In distribution |
| IPN004797 | STAINLESS STEEL /Needle K-60 Size-5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ethibond Excel | Ethicon, Inc. | 175 |
| DemeSTEEL | Demetech Corp. | 150 |
| 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
Recalls
3 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 |
|---|---|---|---|---|---|
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Other | The products are being recalled because they did not meet minimum diameter requirements. | 3,816 ea | 2015-12-17 |
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.