Exact Suture Placement Device
Catalogue number CM3061, listed by Cypris Medical, Inc., United States, under Carrier, Ligature. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Jiangsu MJD Medical Technology Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Cypris Medical, Inc., United States |
|---|---|
| FDA product code | GEJ |
| Device type | Carrier, Ligature |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-10 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM3061 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| MT | Jiangsu MJD Medical Technology Co., Ltd. | 18 |
| V. Mueller | Steris Corporation | 15 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 5 |
| Marina Medical | Marina Medical Instruments, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 5 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 4 |
| Cygnus | Aspen Surgical Products, Inc. | 4 |
Showing 12 of 35. All products under Carrier, Ligature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240185 | 2024-05-03 |
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.