Khaimi Concentrator, 0.25 Ml
Catalogue number 9001-25, listed by Katalyst Surgical, LLC, United States, under Instrument, Clip Removal. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Katalyst Surgical, LLC, United States |
|---|---|
| FDA product code | HBQ |
| Device type | Instrument, Clip Removal |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4200 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9001-25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 4 |
| Vitalitec Clip Removers | Vitalitec International, Inc. | 2 |
| Khaimi Concentrator, 0.35 mL | Katalyst Surgical, LLC | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Clip Remover | Acra CUT, Inc. | 1 |
| Lapro-Clip | Covidien LP | 1 |
| Khaimi Concentrator, 0.33 mL | Katalyst Surgical, LLC | 1 |
| Khaimi Concentrator, Smooth, 0.45 | Katalyst Surgical, LLC | 1 |
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.