Medline
Disposable suction and irrigation system, Surgical irrigation/aspiration handpiece, single-use
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Modern Medical Equipment Mfg., Ltd., Hong Kong |
|---|---|
| FDA product code | FHF |
| Device type | System, Evacuator, Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Record published | 2017-12-16 |
| Record revised | 2019-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 4, white box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89055NS | In distribution | |
| 89056NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Suction Irrigation System | Applied Medical Resources Corp. | 5 |
| Epix® Reusable Probe | Applied Medical Resources Corp. | 4 |
| Irrigation/Aspiration set 1 spike – with handpiece & probe tip, 10mmx33cm | Promepla | 3 |
| Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy – 1 spike | Promepla | 2 |
| Urology – Traxerflow -2 Way Irrigation set Ureteroscopy with laser | Promepla | 2 |
| Laparoscopy – 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip) | Promepla | 2 |
| Irrigation/Aspiration set for RTUP/Post Operative irrigation (Urology) 2 Spikes | Promepla | 2 |
| Urology – Traxerflow | Promepla | 1 |
| KE011 SET Urgencias | Applied Medical Resources Corp. | 1 |
| Hysteroscopy set 2 spikes and aspiration tubing (push fitting) | Promepla | 1 |
| Urology – 1 WAY Turp / Post Operative Irrigation/Aspiration set | Promepla | 1 |
| Chole KIT 24 | Applied Medical Resources Corp. | 1 |
Showing 12 of 71. All products under System, Evacuator, Fluid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093479 | 2010-05-19 |
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.