Scanlan® Surg-I-Loop® Plus With Semi-Sharp Needle
Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - Light Orange, 37cm long, needle 1mm diam, Bulk Non-Sterile (20/pkg)
9manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Scanlan International, Inc., United States |
|---|---|
| FDA product code | GAE |
| Device type | Snare, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-21 |
| Record revised | 2020-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001-82P | In distribution | |
| 1001-82PB | 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 |
| 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 |
| Scanlan® Surg-I-Loop® Plus with blunt needle | Scanlan International, Inc. | 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.