Integra® Jarit®
Integra® Jarit® Millard-Dingman Mouth Gag Set, Includes 3 Tongue Blades: (REF#'s TB100S, TB100M and TB100L)
12manufacturers in China registered for this device type
60catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KBN |
| Device type | Gag, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-02 |
| Record revised | 2025-06-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Width 20 to 73 mm; length 30 to 103 mm; depth 65 to 80 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 450126 | Length 85 mm | In distribution | |
| 450090 | In distribution | ||
| P7830 | In distribution | ||
| P1754 | In distribution | ||
| X7421 | In distribution | ||
| TB100M | 5-7/8″ | In distribution | |
| 450124 | 5-3/8″ | In distribution | |
| 450100 | In distribution | ||
| 450101 | In distribution | ||
| 450167 | In distribution | ||
| 450102 | In distribution | ||
| 450093 | In distribution | ||
| 450165 | In distribution | ||
| TB100L | 5-7/8″ | In distribution | |
| P110 | In distribution | ||
| 450111 | Length 94 mm | In distribution | |
| 450112 | In distribution | ||
| X7431 | In distribution | ||
| 450120 | Length 30 mm | In distribution | |
| P7832 | In distribution | ||
| 450FRM090 | In distribution | ||
| 100E | In distribution | ||
| X7426 | In distribution | ||
| 838250 | In distribution | ||
| 450125 | 5-3/8″ | In distribution | |
| 450103 | In distribution | ||
| PGQ5640INS | In distribution | ||
| 450110RI | 12 | In distribution | |
| 450128 | Width 25 mm | In distribution | |
| 450164 | In distribution | ||
| 450BLD090 | In distribution | ||
| X3249B | In distribution | ||
| 450141 | In distribution | ||
| X3247B | In distribution | ||
| X3245B | In distribution | ||
| P105 | In distribution | ||
| 450163 | In distribution | ||
| 450144 | In distribution | ||
| 450166 | In distribution | ||
| 450140 | In distribution | ||
| 450143 | In distribution | ||
| 450105 | In distribution | ||
| 450106 | In distribution | ||
| P4539 | In distribution | ||
| 450WLP141 | In distribution | ||
| 450122 | 5-3/8″ | In distribution | |
| 450091 | In distribution | ||
| 450160 | In distribution | ||
| 450121 | 5-3/8″ | In distribution | |
| TB100S | Depth 65 mm | In distribution | |
| 450092 | In distribution | ||
| 450142 | In distribution | ||
| 450SBA090 | In distribution | ||
| 450127 | 5-3/8″ | In distribution | |
| P7831 | In distribution | ||
| 450110 | In distribution | ||
| 450113 | In distribution | ||
| 450123 | Length 70 mm | In distribution | |
| 450162 | In distribution | ||
| 450161 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 74 |
| 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.