THD Bandy
THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single…
THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (2), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Tongchuang Medical Instrument Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | THD SPA, Italy |
|---|---|
| FDA product code | FHN |
| Device type | Ligator, Hemorrhoidal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K093497 |
| Record published | 2017-01-18 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 25, pack of 10 |
| Sizes | Length 154 mm; outer diameter 12.8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THD Bandy | Length 154 mm | In distribution |
| THD Bandy | Outer Diameter 12.8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 20 |
| Hemorrhoids Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 16 |
| Millennium | Avalign Technologies, Inc. | 15 |
| Hayden Medical | Hayden Medical Inc | 12 |
| Ligation Device | LEO Medical Co., Ltd. | 12 |
| BR Surgical, LLC | BR Surgical LLC | 11 |
| ESI | FTT Medical, Inc. | 11 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Surtex | Surtex Instruments Ltd | 8 |
| Aesculap | Aesculap AG | 8 |
| Avalign | Avalign Technologies, Inc. | 8 |
Showing 12 of 64. All products under Ligator, Hemorrhoidal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093497 | 2010-07-15 |
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.