Henry Schein
Uterine Sound Simpson
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | HHM |
| Device type | Sound, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2019-05-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1045527 | In distribution | |
| 1047461 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 104 |
| Gimmi | Gimmi Gmbh | 32 |
| HNM Medical | HNM Stainless, LLC. | 13 |
| Aesculap | Aesculap AG | 12 |
| Symmetry Sims | Aspen Surgical Products, Inc. | 9 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 7 |
| BR Surgical, LLC | BR Surgical LLC | 6 |
| GEN2 | Surgix Medical LLC | 6 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Gynex | Gynex Corporation | 6 |
| V. Mueller | Steris Corporation | 6 |
Showing 12 of 43. All products under Sound, Uterine
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.