DeRoyal
ST. Bite Block
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-1828 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope Accessory | Richard Wolf Gmbh | 42 |
| MultiStage® | Dongguan TT Medical, Inc. | 24 |
| Elation™ | Merit Medical Systems, Inc. | 23 |
| Inspira AIR | Acclarent, Inc. | 14 |
| Texas | Richard Wolf Gmbh | 10 |
| Trachealator Non-occlusive Airway Dilation Balloon | Disa Medinotec (PTY) Ltd | 9 |
| Pilling | Teleflex Medical LLC | 8 |
| CRE Pulmonary | Boston Scientific Corporation | 6 |
| Single Use Aspiration Needle | Olympus Medical Systems Corp. | 5 |
| Cook | Cook Incorporated | 3 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
Showing 12 of 37. All products under Bronchoscope Accessory
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.