GeneraBloc Endoscopy Bite Block
Catalogue number GIS-3, listed by GI Supply, United States, under Endoscopic Bite Block. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (21), Zhejiang (14), Shanghai (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Hangzhou Stellarmed Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Suzhou Suning Underpad Co., Ltd. | Suzhou, Jiangsu Province | Contract manufacturer | 11 | |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Yangzhou Chuangyou Science & Technology Development Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 44. All 44 manufacturers in China registered for Endoscopic Bite Block
Record
| Listed by | GI Supply, United States |
|---|---|
| FDA product code | MNK |
| Device type | Endoscopic Bite Block |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K931044 |
| Record published | 2021-07-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Master of 100, dispenser of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GIS-3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Bite Block | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 12 |
| Endoscopic Bite Block | Us Endoscopy | 9 |
| CareGuard® | Diversatek Healthcare Inc | 9 |
| CeroFrict | SML MED-Tech Solutions Limited | 9 |
| Batrik Bitestrong Bite Blocks | Batrik Medical Manufacturing Inc. | 8 |
| Mouthpiece | Olympus Medical Systems Corp. | 8 |
| Key Surgical Bite Blocks | Key Surgical, LLC | 5 |
| Disposable Bite Block | Micro-Tech (Nanjing) Co., Ltd. | 5 |
| Hudson RCI | Teleflex Medical LLC | 5 |
| Sequoia® | Zimmer Spine, Inc. | 5 |
| Inoris Medical Sp. z o.o. | Inoris Medical SP. Z O.O. | 4 |
| Sharn Inc | Sharn Anesthesia | 4 |
Showing 12 of 68. All products under Endoscopic Bite Block
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K931044 | 1993-10-04 |
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.