Rtmed
41 catalogue numbers from 3-0 75cm 1/2 Round Bodied 30mm, listed by Shandong Haidike Medical Products Co., Ltd., China, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
41catalogue numbers in this listing
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 | Shandong Haidike Medical Products Co., Ltd., China |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Manufacturer |
| 510(k) | K212603 |
| Record published | 2022-10-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3-0 75cm 1/2 Round Bodied 30mm | In distribution | |
| 5-0 75cm 3/8 Cutting 16mm | In distribution | |
| 4-0 150cm Without Needle | In distribution | |
| 2# 75cm 1/2 Round Bodied 37mm | In distribution | |
| 3-0 75cm 1/2 Round Bodied 24mm | In distribution | |
| 3-0 75cm Straight Cutting 60mm | In distribution | |
| 2-0 75cm 3/8 Cutting 35mm | In distribution | |
| 6-0 150cm Without Needle | In distribution | |
| 1# 75cm 3/8 Cutting 40mm | In distribution | |
| 1# 75cm 1/2 Round Bodied 37mm | In distribution | |
| 0# 75cm 3/8 Cutting 40mm | In distribution | |
| 0# 150cm Without Needle | In distribution | |
| 1# 75cm 3/8 Reverse Cutting 40mm | In distribution | |
| 3-0 75cm 3/8 Cutting 24mm | In distribution | |
| 6-0 45cm 3/8 Cutting 9mm | In distribution | |
| 0# 75cm 1/2 Round Bodied 40mm | In distribution | |
| 5-0 150cm Without Needle | In distribution | |
| 1# 150cm Without Needle | In distribution | |
| 2-0 75cm Straight Cutting 60mm | In distribution | |
| 2# 150cm Without Needle | In distribution | |
| 2-0 75cm 1/2 Round Bodied 30mm | In distribution | |
| 2-0 75cm 3/8 Cutting 30mm | In distribution | |
| 6-0 60cm 3/8 Reverse Cutting 12mm | In distribution | |
| 5-0 75cm 1/2 Round Bodied 16mm | In distribution | |
| 0# 75cm 3/8 Reverse Cutting 37mm | In distribution | |
| 3-0 150cm Without Needle | In distribution | |
| 3-0 75cm 3/8 Reverse Cutting 26mm | In distribution | |
| 2-0 75cm 3/8 Reverse Cutting 26mm | In distribution | |
| 4-0 75cm 1/2 Round Bodied 24mm | In distribution | |
| 4-0 75cm 3/8 Cutting 24mm | In distribution | |
| 2# 75cm 1/2 Round Bodied 40mm | In distribution | |
| 0# 75cm 1/2 Round Bodied 37mm | In distribution | |
| 4-0 75cm 3/8 Cutting 16mm | In distribution | |
| 0# 75cm 3/8 Cutting 35mm | In distribution | |
| 6-0 45cm 1/2 Round Bodied 10mm | In distribution | |
| 4-0 75cm 3/8 Reverse Cutting 19mm | In distribution | |
| 3-0 75cm 3/8 Cutting 28mm | In distribution | |
| 2-0 150cm Without Needle | In distribution | |
| 1# 75cm 1/2 Round Bodied 40mm | In distribution | |
| 5-0 60cm 3/8 Reverse Cutting 13mm | In distribution | |
| 2# 75cm 3/8 Cutting 40mm | 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
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.