Scanlan® Minimally-Invasive Instrumentation
SCANLAN® Suture Puller
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Auckland Medical Technology (Sichuan) Co., Ltd. | Luzhou | Sichuan | Manufacturer | 3 |
Record
| Listed by | Scanlan International, Inc., United States |
|---|---|
| FDA product code | HCF |
| Device type | Instrument, Ligature Passing And Knot Tying |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-06 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9009-816-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 360 |
| Elmed | Elmed, Inc. | 99 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 69 |
| Millennium | Avalign Technologies, Inc. | 53 |
| Castroviejo Needle Holder | Sontec Instruments, Inc. | 46 |
| Elmed Incorporated | Elmed, Inc. | 38 |
| Aesculap | Aesculap AG | 26 |
| Barraquer Needle Holder | Sontec Instruments, Inc. | 23 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 20 |
| Gimmi | Gimmi Gmbh | 16 |
| Marina Medical | Marina Medical Instruments, Inc. | 16 |
| Weck | Teleflex Medical LLC | 12 |
Showing 12 of 156. All products under Instrument, Ligature Passing And Knot Tying
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.