Ball Point Probe
Heartline Ball Point 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 | 2018-09-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 13.75 in |
| Distribution end date | 2018-09-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2800-7486 | Length 13.75 in | In distribution |
| 2800-7486 | Length 13.75 in | Withdrawn |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.