Sklar®
Censitrac Ready Doyen-Jansen Adult Mouth GAG
12manufacturers in China registered for this device type
55catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | KBN |
| Device type | Gag, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-18 |
| Record revised | 2018-10-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 93-8039 | In distribution | ||
| 75-1116 | In distribution | ||
| 22-8945 | In distribution | ||
| 75-1017 | In distribution | ||
| 75-1040 | In distribution | ||
| 75-1002 | In distribution | ||
| 75-1056 | In distribution | ||
| 75-1114 | In distribution | ||
| 75-1025C | In distribution | ||
| 75-1041 | In distribution | ||
| 75-1015 | In distribution | ||
| 44-463 | In distribution | ||
| 75-1055 | In distribution | ||
| 75-1054 | In distribution | ||
| 75-1110 | In distribution | ||
| 75-1111 | In distribution | ||
| 75-1005 | In distribution | ||
| 75-1016 | In distribution | ||
| 75-1107 | In distribution | ||
| 22-8946 | 2 | In distribution | |
| 75-1113 | In distribution | ||
| 75-1115 | In distribution | ||
| 93-8034 | In distribution | ||
| 75-1058 | In distribution | ||
| 75-1004 | In distribution | ||
| 75-1010 | In distribution | ||
| 93-8038 | In distribution | ||
| 75-1051 | In distribution | ||
| 75-1020 | In distribution | ||
| 75-1024 | In distribution | ||
| 93-8040 | In distribution | ||
| 75-1053 | In distribution | ||
| 75-1112 | In distribution | ||
| 75-1001 | In distribution | ||
| 75-1108 | In distribution | ||
| 75-1018 | In distribution | ||
| 75-1009 | In distribution | ||
| 75-1003 | In distribution | ||
| 75-1042 | In distribution | ||
| 75-1109 | In distribution | ||
| 75-1102 | In distribution | ||
| 75-1012 | In distribution | ||
| 75-1011 | In distribution | ||
| 75-1007 | In distribution | ||
| 75-1025 | In distribution | ||
| 75-1043 | In distribution | ||
| 48-774 | In distribution | ||
| 44-475 | In distribution | ||
| 75-1052 | In distribution | ||
| 75-1059 | In distribution | ||
| 48-785 | In distribution | ||
| 75-1057 | In distribution | ||
| 75-1050 | In distribution | ||
| 75-1008 | In distribution | ||
| 93-8706 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 74 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| 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.