Provox Dilator 20
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE)…
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Yongle Medical Technology Co., Ltd. | Taixing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Atos Medical AB, Sweden |
|---|---|
| FDA product code | LRC |
| Device type | Instrument, Ent Manual Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-01 |
| Record revised | 2024-12-11 (version 5) |
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, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from rain. Keep away from sunlight. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8343 | In distribution | |
| 7123 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Ent Manual Surgical | Karl Storz GmbH & Co. KG | 2,062 |
| Fentex | Fentex medical GmbH | 1,738 |
| Elmed | Elmed, Inc. | 504 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 441 |
| Evonos | Gyrus Acmi, Inc. | 291 |
| Millennium | Avalign Technologies, Inc. | 283 |
| Elmed Incorporated | Elmed, Inc. | 277 |
| Instrument, Ent Manual Surgical | Stryker Leibinger Gmbh & Co. KG | 169 |
| Rhinoforce | Karl Storz GmbH & Co. KG | 112 |
| Surtex | Surtex Instruments Ltd | 85 |
| Kerrison sphenoid punch | Spiggle & Theis Medizintechnik Gmbh | 82 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 78 |
Showing 12 of 661. All products under Instrument, Ent Manual Surgical
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.