Rtmed
39 catalogue numbers from 0# Without Needle 150cm, listed by Shandong Haidike Medical Products Co., Ltd., China, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract 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 | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Manufacturer |
| 510(k) | K231183 |
| Record published | 2024-01-05 |
| Record revised | 2026-04-13 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0# Without Needle 150cm | In distribution | |
| 2-0 Round Bodied 1/2 30mm 75cm | In distribution | |
| 0# Round Bodied 1/2 35mm 75cm | In distribution | |
| 1# Round Bodied 1/2 40mm 75cm | In distribution | |
| 4-0 Round Bodied 1/2 20mm 75cm | In distribution | |
| 4-0 Reverse Cutting 3/8 16mm 75cm | In distribution | |
| 0# Reverse Cutting 3/8 37mm 75cm | In distribution | |
| 4-0 Reverse Cutting 3/8 19mm 75cm | In distribution | |
| 3-0 Without Needle 150cm | In distribution | |
| 5-0 Cutting 3/8 12mm 75cm | In distribution | |
| 2# Reverse Cutting 3/8 42mm 75cm | In distribution | |
| 5-0 Without Needle 150cm | In distribution | |
| 0# Cutting 3/8 40mm 75cm | In distribution | |
| 2-0 Without Needle 150cm | In distribution | |
| 3-0 Cutting 3/8 19mm 75cm | In distribution | |
| 2-0 Cutting 3/8 30mm 75cm | In distribution | |
| 1# Reverse Cutting 3/8 42mm 75cm | In distribution | |
| 6-0 Without Needle 150cm | In distribution | |
| 3-0 Cutting 3/8 24mm 75cm | In distribution | |
| 2# Cutting 3/8 40mm 75cm | In distribution | |
| 2# Round Bodied 1/2 40mm 75cm | In distribution | |
| 6-0 Cutting 3/8 9mm 45cm | In distribution | |
| 2-0 Reverse Cutting 3/8 37mm 75cm | In distribution | |
| 3-0 Round Bodied 1/2 20mm 75cm | In distribution | |
| 2-0 Reverse Cutting 3/8 26mm 75cm | In distribution | |
| 6-0 Round Bodied 1/2 13mm 75cm | In distribution | |
| 3-0 Round Bodied 1/2 24mm 75cm | In distribution | |
| 1# Cutting 3/8 40mm 75cm | In distribution | |
| 2# Without Needle 150cm | In distribution | |
| 4-0 Without Needle 150cm | In distribution | |
| 3-0 Reverse Cutting 3/8 26mm 75cm | In distribution | |
| 2-0 Round Bodied 1/2 24mm 75cm | In distribution | |
| 1# Without Needle 150cm | In distribution | |
| 0# Round Bodied 1/2 30mm 75cm | In distribution | |
| 6-0 Round Bodied 1/2 10mm 45cm | In distribution | |
| 0# Cutting 3/8 35mm 75cm | In distribution | |
| 2-0 Cutting 3/8 35mm 75cm | In distribution | |
| 5-0 Round Bodied 1/2 13mm 75cm | In distribution | |
| 2# Round Bodied 1/2 45mm 75cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231183 | 2023-08-25 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | 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.