Endolaryngeal Probe
Endolaryngeal Probe Microscopic Straight Button-END
3manufacturers in China registered for this device type
1catalogue number
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 | KAK |
| Device type | Probe, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-27 |
| Record revised | 2024-01-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 10 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1301-515 | Length 10 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 52 |
| MicroFrance® | Integra Microfrance SAS | 34 |
| Pilling | Teleflex Medical LLC | 20 |
| HNM Medical | HNM Stainless, LLC. | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 17 |
| mytaMed | Mytamed, Inc. | 16 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 15 |
| V. Mueller | Steris Corporation | 12 |
| Bowman salivary duct probe | Spiggle & Theis Medizintechnik Gmbh | 11 |
| Millennium | Avalign Technologies, Inc. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
Showing 12 of 52. All products under Probe, Ent
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.