Helmut Zepf
GAG, Mouth Packung Unit = 2 Pieces Mouth Gags Blue, Small, Silicone, 4,5 X 3,2 X 2,85 CM
12manufacturers in China registered for this device type
6catalogue 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 | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | KBN |
| Device type | Gag, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2024-01-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37.271.12 | In distribution | |
| 37.261.14 | In distribution | |
| 37.261.11 | In distribution | |
| 37.258.43 | In distribution | |
| 37.271.00 | In distribution | |
| 37.258.40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 74 |
| 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 |
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.