Deknatel
Nylon Green Monofilament Nylon Suture Size 3-0 30" T-2 Needle
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2026-04-13 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 36, box of 12, sleeve |
| Sizes | Length 90 to 150 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN009110 | Length 150 cm | In distribution |
| IPN000846 | Suture length 24″, Needle length.700″ | In distribution |
| IPN029156 | Length 90 cm | In distribution |
| IPN026804 | Length 120 cm | In distribution |
| IPN000842 | Suture Length 30″, Needle Length.700″ | In distribution |
| IPN009330 | NYLON /Needle C-12 Size-2 | In distribution |
| IPN029154 | Length 90 cm | In distribution |
| IPN009109 | Length 150 cm | In distribution |
| IPN029157 | Length 120 cm | In distribution |
| IPN000846 | Suture length 24″, Needle length.700″ | In distribution |
| IPN009075 | Length 90 cm | In distribution |
| IPN009066 | Length 90 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| Monosof | Covidien LP | 256 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 127 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
Recalls
1 of these is 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. |
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.