Eigr™ Saber Waveguide
The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
Who Else Makes It
Concentrated in Jiangsu (22), Zhejiang (20), Guangdong (10). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 70. All 70 manufacturers in China registered for Catheter And Tip, Suction
Record
| Listed by | Invuity, Inc., United States |
|---|---|
| FDA product code | JOL |
| Device type | Catheter And Tip, Suction |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Premarket notification | Exempt |
| Record published | 2016-07-12 |
| Record revised | 2020-04-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Yankauer, Fin Tip | Tip: Fin | In distribution |
| Yankauer, Metal Tip | Tip: Metal | In distribution |
| Yankauer, Bulb Tip | Tip: Bulb | In distribution |
| Yankauer, Taper Tip | Tip: Taper | In distribution |
| Frazier, 12Fr | Suction Tube: 12 French | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 679 |
| Gen2 | Surgix Medical LLC | 497 |
| Avalign | Avalign Technologies, Inc. | 459 |
| Ambler Surgical | Ambler Surgical, LLC | 369 |
| Surtex | Surtex Instruments Ltd | 282 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 281 |
| V. Mueller | Steris Corporation | 230 |
| Liposuction Cannula | Sontec Instruments, Inc. | 159 |
| Pilling | Teleflex Medical LLC | 135 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 127 |
| Argyle | Cardinal Health 200, LLC | 125 |
| Argyle | Cardinal Health | 117 |
Showing 12 of 397. All products under Catheter And Tip, Suction
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-05-12 | Class II | Other | Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. | 197 devices | 2013-04-23 |
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.