Tube
13 catalogue numbers from 18-528-20-01, listed by KLS-Martin L.P., United States, under Tube, Tonsil Suction. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | KCB |
| Device type | Tube, Tonsil Suction |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-04-18 (version 8) |
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 |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-528-20-01 | 7.5 CM | In distribution |
| 18-523-20-04 | Withdrawn | |
| 18-530-40-01 | 21 CM | Withdrawn |
| 18-506-18-07 | 18 CM | Withdrawn |
| 18-503-18-07 | 18 CM | Withdrawn |
| 18-503-14-07 | 14 CM | Withdrawn |
| 18-504-14-07 | 14 CM | Withdrawn |
| 18-504-18-07 | 18 CM | Withdrawn |
| 18-579-23-01 | 23 CM | Withdrawn |
| 18-563-31-01 | 31 CM | Withdrawn |
| 18-523-18-04 | Withdrawn | |
| 18-530-33-01 | 19 CM | Withdrawn |
| 18-506-14-07 | 14 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 364 |
| Ambler Surgical | Ambler Surgical, LLC | 88 |
| Suction Tube | KLS-Martin L.P. | 71 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 70 |
| MicroFrance® | Integra Microfrance SAS | 47 |
| HNM Medical | HNM Stainless, LLC. | 43 |
| devemed | Devemed Gmbh | 32 |
| mytaMed | Mytamed, Inc. | 31 |
| Novo Surgical | Novo Surgical, Inc. | 31 |
| Reicodent | Devemed Gmbh | 30 |
| Pilling | Teleflex Medical LLC | 21 |
| Bear | Mytamed, Inc. | 16 |
Showing 12 of 40. All products under Tube, Tonsil Suction
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.