Fundus Sound
FUNDUS SOUND XM Intrauterine Sound
5manufacturers in China registered for this device type
1catalogue number
2recalls on this code
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HHM |
| Device type | Sound, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-30 |
| Record revised | 2024-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1196 | 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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-07-31 | Class II | Process control | During the manufacturing process the devices were laser-marked with the incorrect part number. | 468 units |
| 2024-07-31 | Class II | Process control | During the manufacturing process the devices were laser-marked with the incorrect part number. | 657 units |
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.