Medicon
Köln frame only w 1 pair tooth hooks cvd f 45.52.30
12manufacturers in China registered for this device type
74catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Shanghai (2).
| 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 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangsu Kangjin Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Golden Wish Personal Care Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
Record
| Listed by | Medicon eG. Chirurgiemechaniker-Genossenschaft |
|---|---|
| FDA product code | KBN |
| Device type | Gag, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 45.53.63 | In distribution | ||
| 72.05.10 | In distribution | ||
| 45.51.21 | In distribution | ||
| 45.53.62 | In distribution | ||
| 45.54.05 | In distribution | ||
| 45.51.02 | In distribution | ||
| 72.07.09 | In distribution | ||
| 45.53.61 | In distribution | ||
| 72.05.60 | In distribution | ||
| 45.51.27 | In distribution | ||
| 45.51.64 | In distribution | ||
| 45.54.03 | In distribution | ||
| 72.08.13 | In distribution | ||
| 45.51.14 | In distribution | ||
| 45.54.02 | In distribution | ||
| 45.52.17 | In distribution | ||
| 72.07.51 | In distribution | ||
| 72.05.63 | In distribution | ||
| 45.52.16 | In distribution | ||
| 72.07.11 | In distribution | ||
| 72.07.35 | In distribution | ||
| 45.53.50 | In distribution | ||
| 45.52.11 | In distribution | ||
| 45.57.12 | In distribution | ||
| 72.07.53 | In distribution | ||
| 45.52.14 | In distribution | ||
| 72.07.13 | In distribution | ||
| 45.51.22 | In distribution | ||
| 45.52.19 | In distribution | ||
| 45.57.19 | In distribution | ||
| 45.52.23 | In distribution | ||
| 72.07.29 | In distribution | ||
| 45.52.02 | In distribution | ||
| 45.57.15 | In distribution | ||
| 45.51.62 | In distribution | ||
| 72.05.61 | In distribution | ||
| 45.57.02 | In distribution | ||
| 45.57.13 | In distribution | ||
| 45.57.14 | In distribution | ||
| 72.08.11 | In distribution | ||
| 45.52.32 | 2 | In distribution | |
| 45.53.20 | In distribution | ||
| 45.53.80 | In distribution | ||
| 72.08.12 | In distribution | ||
| 45.51.12 | In distribution | ||
| 45.54.07 | In distribution | ||
| 45.57.11 | In distribution | ||
| 72.08.00 | In distribution | ||
| 72.05.15 | In distribution | ||
| 45.57.22 | In distribution | ||
| 45.52.12 | In distribution | ||
| 72.08.20 | In distribution | ||
| 72.07.49 | In distribution | ||
| 45.52.15 | In distribution | ||
| 72.07.15 | In distribution | ||
| 45.51.11 | In distribution | ||
| 72.07.63 | In distribution | ||
| 45.52.22 | In distribution | ||
| 72.07.03 | In distribution | ||
| 45.51.15 | In distribution | ||
| 45.53.00 | In distribution | ||
| 72.07.61 | In distribution | ||
| 45.52.31 | In distribution | ||
| 45.51.65 | In distribution | ||
| 45.52.33 | 2 | In distribution | |
| 45.54.06 | In distribution | ||
| 72.07.33 | In distribution | ||
| 45.53.11 | In distribution | ||
| 45.52.13 | In distribution | ||
| 45.53.12 | In distribution | ||
| 45.53.13 | In distribution | ||
| 45.51.13 | In distribution | ||
| 45.51.63 | In distribution | ||
| 72.07.31 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| Sklar® | Sklar Corporation | 55 |
| Millennium | Avalign Technologies, Inc. | 51 |
| Ambler Surgical | Ambler Surgical, LLC | 49 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 43 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 41 |
| Aesculap | Aesculap AG | 41 |
| V. Mueller | Steris Corporation | 39 |
| Novo Surgical | Novo Surgical, Inc. | 38 |
| Avalign | Avalign Technologies, Inc. | 33 |
| Integra® | Integra LifeSciences Production Corporation | 31 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 29 |
Showing 12 of 99. All products under Gag, Mouth
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.