Oracle
The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endoscopes endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower…
The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endoscopes endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K111028 |
| Record published | 2020-04-02 |
| Record revised | 2023-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 20, box of 20 |
| Distribution end date | 2022-11-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711892 | In distribution | |
| 00711892 | Withdrawn | |
| 00711891 | Withdrawn | |
| 00711891 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fuse | Endochoice, Inc. | 52 |
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
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.