Magnetic Probe
Heartline Magnetic Probe
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | FGM |
| Device type | Probe And Director, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-07 |
| Record revised | 2024-05-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 13.75 in |
| Distribution end date | 2018-09-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2800-7480 | Length 13.75 in | In distribution |
| 2800-7480 | Length 13.75 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 58 |
| Millennium | Avalign Technologies, Inc. | 42 |
| V. Mueller | Steris Corporation | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 41 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| HNM Medical | HNM Stainless, LLC. | 14 |
| Universal Probe | Sontec Instruments, Inc. | 11 |
| Peak Medical | Peak Medical Distribution Inc | 8 |
| Aesculap | Aesculap AG | 7 |
| Quinelato | Schobell Industrial Ltda | 7 |
| Grooved Director | Sontec Instruments, Inc. | 7 |
| Hayden Medical | Hayden Medical Inc | 5 |
Showing 12 of 41. All products under Probe And Director, Gastro-Urology
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.