Fabco
10 mm Cherry-tipped Endoscopic Dissector Stick
14manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (3), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Showing 12 of 14. All 14 manufacturers in China registered for Dissector, Surgical, General & Plastic Surgery
Record
| Listed by | First AID Bandage Co Inc |
|---|---|
| FDA product code | GDI |
| Device type | Dissector, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2020-05-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Dispenser box of 10 |
| Sizes | Outer diameter 0.25 to 0.375 in; outer diameter 5 to 10 mm; length 0.625 to 1.5 in; length 15.9 to 400 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 31051010 | Outer Diameter.375 in | 5 | In distribution |
| 34911510 | Outer Diameter.375 in | 5 | In distribution |
| 31101010 | Outer Diameter.375 in | 5 | In distribution |
| 34912010 | Outer Diameter.375 in | 5 | In distribution |
| 35200511 | Length 15.9 mm | 500 | In distribution |
| 37001010 | Length 400 mm | In distribution | |
| 34901510 | Outer Diameter.375 in | 5 | In distribution |
| 31001010 | Outer Diameter 0.25 in | 5 | In distribution |
| 31201010 | Outer Diameter.375 in | 5 | In distribution |
| 37000010 | Outer Diameter 10 mm | In distribution | |
| 37002010 | Outer Diameter 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lazic | Peter Lazic Gmbh | 154 |
| Gimmi | Gimmi Gmbh | 129 |
| Life Instruments | Life Instrument Corp. | 103 |
| Ambler Surgical | Ambler Surgical, LLC | 90 |
| Aesculap | Aesculap AG | 84 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 68 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 68 |
| Boss Instruments | Boss Instruments, Ltd. | 67 |
| Marina Medical | Marina Medical Instruments, Inc. | 59 |
| Hayden Medical | Hayden Medical Inc | 57 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 55 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 48 |
Showing 12 of 214. All products under Dissector, Surgical, General & Plastic Surgery
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Carwild Corp. | UDI-DI | 2022-08-02 | Class II | Component change control | Sterility with new cotton source not validated | 90 CASES (4500 EACHES) |
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.