Supramid Extra
3/8 Circle Micro-Cutting Taper Point Needle (18.7mm), USP 3-0 SUPRAMID EXTRA white cable-type Nylon, 20" Loop
3manufacturers in China registered for this device type
119catalogue numbers in this listing
4510(k) clearances naming this product code
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 | S. Jackson, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Manufacturer |
| Record published | 2017-08-02 |
| Record revised | 2026-04-13 (version 5) |
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 |
| Packaging | Box of 12, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Code GI-30B | In distribution | |
| Code XHEA-30-20 | In distribution | |
| Code EA-40B | In distribution | |
| Code SK-40 | In distribution | |
| Code CE-10 | In distribution | |
| Code SOM-01 | In distribution | |
| Code ER-20-36 | In distribution | |
| Code CL-10 | In distribution | |
| Code XHEA-30 | In distribution | |
| Code EA-40 | In distribution | |
| Code SOHM-03 | In distribution | |
| Code FT-30 | In distribution | |
| Code PL-20 | In distribution | |
| Code ER-30B-18 | In distribution | |
| Code 2S-1-40 | In distribution | |
| Code LC-30 | In distribution | |
| Code ER-40-18 | In distribution | |
| Code GT-20-24 | In distribution | |
| Code 2CR-40 | In distribution | |
| Code SOM-08 | In distribution | |
| Code SOM-20 | In distribution | |
| Code PL-10 | In distribution | |
| Code OS-40 | In distribution | |
| Code 2ER-20 | In distribution | |
| Code ER-20-18 | In distribution | |
| Code JC-02 | In distribution | |
| Code PR-30 | In distribution | |
| Code PL-30 | In distribution | |
| Code HEA-40 | In distribution | |
| Code XHEA-40 | In distribution | |
| Code 2S-1-30 | In distribution | |
| Code HEA-30-40 | In distribution | |
| Code HEA-40-20 | In distribution | |
| Code HEA-40-36 | In distribution | |
| Code GC-20 | In distribution | |
| Code OS-30 | In distribution | |
| Code HEA-30-26 | In distribution | |
| Code LC-40 | In distribution | |
| Code XHEA-40B-20 | In distribution | |
| Code HEA-30-36 | In distribution | |
| Code ER-30-36 | In distribution | |
| Code PL-20B | In distribution | |
| Code SOHM-01 | In distribution | |
| Code OS-40B | In distribution | |
| Code 2EA-40 | In distribution | |
| Code 2JB-20B | In distribution | |
| Code 2ER-40 | In distribution | |
| Code 2JB-20 | In distribution | |
| Code SOM-30 | In distribution | |
| Code 2HEA-30 | In distribution | |
| Code GT-20 | In distribution | |
| Code 2LC-40B | In distribution | |
| Code XHEA-30B-20 | In distribution | |
| Code 2ER-30 | In distribution | |
| Code CP-20 | In distribution | |
| Code CE-20 | In distribution | |
| Code 2CR-30 | In distribution | |
| Code ER-40-36 | In distribution | |
| Code PR-40B | In distribution | |
| Code HEA-30-20 | In distribution | |
| Code GI-20 | In distribution | |
| Code GI-30 | In distribution | |
| Code CL-20 | In distribution | |
| Code HEA-40-40 | In distribution | |
| Code 2LC-40 | In distribution | |
| Code SOM-40 | In distribution | |
| Code RJH-40 | In distribution | |
| Code CP-40 | In distribution | |
| Code CP-30 | In distribution | |
| Code LHR-40-40 | In distribution | |
| Code PR-30-36 | In distribution | |
| Code ER-40B-36 | In distribution | |
| Code PR-30B-36 | In distribution | |
| Code 2S-1-40B | In distribution | |
| Code PR-40 | In distribution | |
| Code LC-40B | In distribution | |
| Code HEA-40-26 | In distribution | |
| Code CO-10 | In distribution | |
| Code XHEA-40-20 | In distribution | |
| Code LCW-40 | In distribution | |
| Code PL-30B | In distribution | |
| Code RJH-40-20 | In distribution | |
| Code SOM-02 | In distribution | |
| Code UCSD-SO-20 | In distribution | |
| Code PR-40-36 | In distribution | |
| Code CO-01 | In distribution | |
| Code EA-30 | In distribution | |
| Code GI-20B | In distribution | |
| Code RJH-40-40 | In distribution | |
| Code CL-01 | In distribution | |
| Code 2GS-2-30B | In distribution | |
| Code LHL-40 | In distribution | |
| Code LHR-40 | In distribution | |
| Code 2HEA-40 | In distribution | |
| Code 2HEA-40-20 | In distribution | |
| Code 2VN-40 | In distribution | |
| Code CL-30 | In distribution | |
| Code HEA-30 | In distribution | |
| Code 2S-2-40 | In distribution | |
| Code 2HEA-30-20 | In distribution | |
| Code JJ-03 | In distribution | |
| Code LD-08 | In distribution | |
| Code ER-30-18 | In distribution | |
| Code PR-30B | In distribution | |
| Code SOM-03 | In distribution | |
| Code LCW-40-20 | In distribution | |
| Code 2OS-40 | In distribution | |
| Code ER-30B-36 | In distribution | |
| Code 2FO-40 | In distribution | |
| Code SOM-10 | In distribution | |
| Code 2GS-1-30 | In distribution | |
| Code 2LA-40 | In distribution | |
| Code HEA-50 | In distribution | |
| Code 2GS-2-30 | In distribution | |
| Code PL-40 | In distribution | |
| Code GI-40 | In distribution | |
| Code ER-40B-18 | In distribution | |
| Code PR-40B-36 | In distribution | |
| Code 2LC-30 | 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 |
| 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 |
| Trelon | B Braun Surgical SA | 72 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K931612 | 1993-12-17 |
| K931613 | 1993-12-17 |
| K912429 | 1991-10-02 |
| K904052 | 1990-10-25 |
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.