Ambler Surgical
Sofferman needle holder, 6 1/4'', straight 93.0mm shaft, delicate, 5.0mm serrated jaws, ring handle with ratchet catch
11manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Yongle Medical Technology Co., Ltd. | Taixing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | LRC |
| Device type | Instrument, Ent Manual Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Barany hard rubber tip only | In distribution | |
| Cottle needle holder | In distribution | |
| Cottle needle holder | In distribution | |
| Shea forward searcher pick | In distribution | |
| Sofferman needle holder | In distribution | |
| Rainer-Alexander ear syringe | In distribution | |
| Rainer-Alexander ear syringe | In distribution | |
| Rainer-Alexander ear syringe | In distribution | |
| Barany noisee apparatus | In distribution | |
| House gelfoam press | In distribution | |
| Laborde tracheal dilator forceps | In distribution | |
| Shea prosthesis placement hook | In distribution | |
| Sheehy fascia press | In distribution | |
| Paparella instrument rack | In distribution | |
| Rainer-Alexander ear syringe shield | In distribution | |
| Rainer-Alexander ear syringe tips | In distribution | |
| Schuknecht spatula | In distribution | |
| Rainer-Alexander ear syringe tips | In distribution | |
| Ambler ear syringe | In distribution | |
| Trousseau tracheal dilator forceps | In distribution | |
| Trousseau tracheal dilator forceps | In distribution | |
| Ambler ear syringe | In distribution | |
| House gelfoam press | In distribution | |
| Rainer-Alexander ear syringe | In distribution | |
| Paparella tissue press | In distribution | |
| Ambler ear syringe | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Ent Manual Surgical | Karl Storz GmbH & Co. KG | 2,062 |
| Fentex | Fentex medical GmbH | 1,738 |
| Elmed | Elmed, Inc. | 504 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 441 |
| Evonos | Gyrus Acmi, Inc. | 291 |
| Millennium | Avalign Technologies, Inc. | 283 |
| Elmed Incorporated | Elmed, Inc. | 277 |
| Instrument, Ent Manual Surgical | Stryker Leibinger Gmbh & Co. KG | 169 |
| Rhinoforce | Karl Storz GmbH & Co. KG | 112 |
| Surtex | Surtex Instruments Ltd | 85 |
| Kerrison sphenoid punch | Spiggle & Theis Medizintechnik Gmbh | 82 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 78 |
Showing 12 of 661. All products under Instrument, Ent Manual 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.