Cook
Cook Retrograde Intubation Set
5manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Cook Incorporated, 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, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G10554 | In distribution | |
| G09727 | In distribution | |
| G07647 | 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 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Compass Steerable Needle | Serpex Medical, Inc. | 2 |
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.