SaddleLoop 18g X 10cm With Blunt Needle
Catalogue number 1541, listed by Quest Medical, Inc., United States, under Snare, Surgical. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (4), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Cixi Bohong Bath Appliances Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Quest Medical, Inc., United States |
|---|---|
| FDA product code | GAE |
| Device type | Snare, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-10 |
| Record revised | 2020-01-15 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1541 | 16 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Scanlan® Surg-I-Loop® silicone loops | Scanlan International, Inc. | 20 |
| Snare, Surgical | Anrei Medical(HZ) Co., Ltd. | 6 |
| Cold Snare | Micro-Tech (Nanjing) Co., Ltd. | 4 |
| LesionHunter(TM) Rotatable Nitinol Cold Snare | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Surgical Support Tie | LivaNova USA, Inc. | 3 |
| Medline | Medline Industries, Inc. | 3 |
| Swift Loop | Coroneo, Inc. | 3 |
| Scanlan® Surg-I-Loop® Plus with semi-sharp needle | Scanlan International, Inc. | 2 |
| Medline Renewal | Medline Industries, Inc. | 2 |
| LiNA OperaScopeTM Lasso | LiNA Medical AG | 2 |
| LiNA OperaScope Angled Lasso | LiNA Medical AG | 2 |
| LiNA OperaScope™ Lasso | LiNA Medical AG | 2 |
Showing 12 of 32. All products under Snare, Surgical
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.