Helmut Zepf
Augmentation Material Applicator Bionik Handle, Cobalt Blue, Double-Ended Plugger, Tips Turned 15° Oppositely,
186manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (40), Jiangsu (35), Guangdong (32). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
Showing 12 of 186. All 186 manufacturers in China registered for Applicator, Absorbent Tipped, Non-Sterile
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | KXF |
| Device type | Applicator, Absorbent Tipped, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6025 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-16 |
| Record revised | 2023-11-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47.848.05 | In distribution | |
| 19.603.15TI | In distribution | |
| 24.548.03 | In distribution | |
| 19.714.21 | In distribution | |
| 19.600.25 | In distribution | |
| 19.199.24 | In distribution | |
| 24.548.02 | In distribution | |
| 47.099.25 | In distribution | |
| 47.099.20 | In distribution | |
| 24.548.04 | In distribution | |
| 19.714.22 | In distribution | |
| 19.199.12 | In distribution | |
| 19.603.10 | In distribution | |
| 19.714.16 | In distribution | |
| 19.600.18 | In distribution | |
| 47.848.04 | In distribution | |
| 47.848.00 | In distribution | |
| 19.603.15 | In distribution | |
| 41.751.46 | In distribution | |
| 19.603.10TI | In distribution | |
| 47.530.00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan® | Puritan Medical Products Company LLC | 36 |
| JMU | JMU Dental, Inc | 22 |
| SmartPractice | Smarthealth, Inc. | 21 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| Avanos | Avanos Medical, Inc. | 16 |
| Q-Care | Sage Products LLC | 13 |
| Ballard™ | SunMed Group Holdings, LLC | 13 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 10 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 10 |
| Puritan® PurFlock Ultra® | Puritan Medical Products Company LLC | 9 |
| Plasdent | Plasdent Corp. | 9 |
| AMD-Ritmed Solon | AMD Medicom Inc. | 9 |
Showing 12 of 98. All products under Applicator, Absorbent Tipped, Non-Sterile
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.