Ambler Surgical
Leksell rongeur, 9'', double-action, slightly curved jaws, 4.0mm x 16.0mm bite, with teeth, spring handle
11manufacturers in China registered for this device type
91catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-07 |
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 |
|---|---|---|
| Beyer rongeur | In distribution | |
| Bane rongeur | In distribution | |
| Luer rongeur | In distribution | |
| Reiner rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Klienert-Kutz rongeur | In distribution | |
| Reiner rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Jansen bone rongeur | In distribution | |
| Ruskin-mini rongeur | In distribution | |
| Friedman micro rongeur | In distribution | |
| Reiner rongeur | In distribution | |
| Cushing rongeur | In distribution | |
| Ruskin-mini rongeur | In distribution | |
| Adson cranial ronguer | In distribution | |
| Blumenthal rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Hakansson rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Zielke rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Urschel-Leksell rongeur | In distribution | |
| Stookey-Bacon cranial rongeur | In distribution | |
| Mead ”Cleveland” rongeur | In distribution | |
| Hartman rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Friedman micro rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Dale first rib rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Beyer rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Blumenthal rongeur | In distribution | |
| Stookey rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Friedman micro rongeur | In distribution | |
| Jansen bone rongeur | In distribution | |
| Zielke rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Mead rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Luer rongeur | In distribution | |
| Kleinert-Kutz synovectomy rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Kleinert-Kutz synovectomy rongeur | In distribution | |
| Friedman micro rongeur | In distribution | |
| Friedman rongeur | In distribution | |
| Zaufal-Jansen rongeur | In distribution | |
| Bone rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Cicherelli rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Blumenthal rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Dawson-Yuhl-Leksell rongeur | In distribution | |
| Olivecrona rongeur | In distribution | |
| Ruskin-mini rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Klienert-Kutz rongeur | In distribution | |
| Beyer rongeur | In distribution | |
| Cottle-Jansen rongeur | In distribution | |
| Jansen bone rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Luer rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Cushing rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Bane rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Luer rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Ruskin-mini rongeur | In distribution | |
| Friedman rongeur | In distribution | |
| Adson rongeur | In distribution | |
| Synovectomy rongeur | In distribution | |
| Ruskin-mini rongeur | In distribution | |
| Leksell rongeur | In distribution | |
| Lempert rongeur | In distribution | |
| Mead rongeur | In distribution | |
| Juers-Lempert rongeur | In distribution | |
| Friedman micro rongeur | In distribution | |
| Friedman rongeur | In distribution | |
| Hartman rongeur | In distribution | |
| Mead rongeur | In distribution | |
| Olivecrona rongeur | In distribution | |
| Beyer rongeur | In distribution | |
| Luer-Friedmann rongeur | In distribution | |
| Beyer rongeur | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 2,994 |
| Life Instruments | Life Instrument Corp. | 1,252 |
| Novo Surgical | Novo Surgical, Inc. | 1,227 |
| Surgical Direct | Surgical Direct, Inc. | 1,208 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 712 |
| gSource | Gsource, LLC. | 509 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 397 |
| Peak MED | Peak Medical Distribution Inc | 320 |
| Aesculap | Aesculap AG | 264 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 244 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 239 |
| HNM Medical | HNM Stainless, LLC. | 186 |
Showing 12 of 438. All products under Rongeur
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.