Mytamed
Claire Ear Hook, 90 Degree Tips, 1.5 and 2.0mm
3manufacturers in China registered for this device type
16catalogue 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 | Mytamed, Inc. |
|---|---|
| FDA product code | KAK |
| Device type | Probe, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2018-02-15 |
| Record revised | 2025-07-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.16.02 | Withdrawn | |
| 6.16.01 | Withdrawn | |
| 6.15.02 | Withdrawn | |
| 6.17.03 | Withdrawn | |
| 6.15.05 | Withdrawn | |
| 6.18.01 | Withdrawn | |
| 6.15.06 | Withdrawn | |
| 6.16.03 | Withdrawn | |
| 7.07.71 | Withdrawn | |
| 7.07.70 | Withdrawn | |
| 6.17.04 | Withdrawn | |
| 8.01.01 | Withdrawn | |
| 6.17.02 | Withdrawn | |
| 6.17.01 | Withdrawn | |
| 6.15.01 | Withdrawn | |
| 6.15.03 | Withdrawn |
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 |
| 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 |
| Avalign | Avalign Technologies, Inc. | 9 |
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.