Avalign
Enucleator, Micro, Left WL 120mm(4 3/4")OL 240mm(9 1/2")
6manufacturers in China registered for this device type
186catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | GZX |
| Device type | Instrument, Microsurgical |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4525 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (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 |
|---|---|---|
| VM82-6536 | In distribution | |
| VM82-7222 | In distribution | |
| VM83-7412 | In distribution | |
| VM82-64411 | In distribution | |
| VM81-8793 | In distribution | |
| VM83-3261 | In distribution | |
| VM82-6214 | In distribution | |
| VM82-6209 | In distribution | |
| VM81-8780 | In distribution | |
| VM82-50711 | In distribution | |
| VM82-62295 | In distribution | |
| VM82-5085 | In distribution | |
| VM81-8728 | In distribution | |
| VM83-7511 | In distribution | |
| VM82-6215 | In distribution | |
| VM82-6422 | In distribution | |
| VM81-8755 | In distribution | |
| VM82-62145 | In distribution | |
| VM83-9721 | In distribution | |
| VM81-8703 | In distribution | |
| VM82-5150 | In distribution | |
| VM82-6208 | In distribution | |
| VM81-8734 | In distribution | |
| VM81-8758 | In distribution | |
| VM81-8718 | In distribution | |
| VM83-7453 | In distribution | |
| VM82-6561 | In distribution | |
| VM81-8795 | In distribution | |
| VM81-8788 | In distribution | |
| VM81-8719 | In distribution | |
| VM83-7441 | In distribution | |
| VM83-7551 | In distribution | |
| VM82-50751 | In distribution | |
| VM82-6441 | In distribution | |
| VM82-6481 | In distribution | |
| VM81-8762 | In distribution | |
| VM82-7283 | In distribution | |
| VM83-7471 | In distribution | |
| VM81-8796 | In distribution | |
| VM83-96415 | In distribution | |
| VM81-8731 | In distribution | |
| VM81-8726 | In distribution | |
| VM81-8710 | In distribution | |
| VM82-50791 | In distribution | |
| VM83-7525 | In distribution | |
| VM82-7421 | In distribution | |
| VM83-7473 | In distribution | |
| VM82-6445 | In distribution | |
| VM82-5145 | In distribution | |
| VM81-8724 | In distribution | |
| VM82-6224 | In distribution | |
| VM81-8723 | In distribution | |
| VM82-62155 | In distribution | |
| VM82-6221 | In distribution | |
| VM81-8725 | In distribution | |
| VM81-8799 | In distribution | |
| VM82-50831 | In distribution | |
| VM82-7211 | In distribution | |
| VM82-6212 | In distribution | |
| VM82-64325 | In distribution | |
| VM83-96515 | In distribution | |
| VM83-7301 | In distribution | |
| VM81-8791 | In distribution | |
| VM82-6225 | In distribution | |
| VM81-8794 | In distribution | |
| VM83-7306 | In distribution | |
| VM83-3266 | In distribution | |
| VM81-8716 | In distribution | |
| VM81-8768 | In distribution | |
| VM82-64195 | In distribution | |
| VM82-62185 | In distribution | |
| VM83-7523 | In distribution | |
| VM83-4146 | In distribution | |
| VM82-6207 | In distribution | |
| VM83-9672 | In distribution | |
| VM81-8786 | In distribution | |
| VM81-8733 | In distribution | |
| VM83-74715 | In distribution | |
| VM81-8727 | In distribution | |
| VM82-6216 | In distribution | |
| VM82-7419 | In distribution | |
| VM83-7463 | In distribution | |
| VM81-8773 | In distribution | |
| VM82-50811 | In distribution | |
| VM82-6442 | In distribution | |
| VM82-7484 | In distribution | |
| VM82-62175 | In distribution | |
| VM81-8789 | In distribution | |
| VM83-7403 | In distribution | |
| VM83-7515 | In distribution | |
| VM82-64515 | In distribution | |
| VM82-62225 | In distribution | |
| VM82-62265 | In distribution | |
| VM81-8757 | In distribution | |
| VM81-8701 | In distribution | |
| VM82-6213 | In distribution | |
| VM82-6553 | In distribution | |
| VM81-8790 | In distribution | |
| VM82-6271 | In distribution | |
| VM82-6219 | In distribution | |
| VM82-6204 | In distribution | |
| VM81-8732 | In distribution | |
| VM81-8767 | In distribution | |
| VM83-7527 | In distribution | |
| VM83-7755 | In distribution | |
| VM82-5143 | In distribution | |
| VM83-7451 | In distribution | |
| VM82-6217 | In distribution | |
| VM81-8737 | In distribution | |
| VM81-8735 | In distribution | |
| VM83-7491 | In distribution | |
| VM82-7481 | In distribution | |
| VM83-7553 | In distribution | |
| VM81-8776 | In distribution | |
| VM81-8717 | In distribution | |
| VM82-5151 | In distribution | |
| VM81-8785 | In distribution | |
| VM82-6431-5 | In distribution | |
| VM82-7286 | In distribution | |
| VM82-6447 | In distribution | |
| VM83-7411 | In distribution | |
| VM82-62215 | In distribution | |
| VM81-8763 | In distribution | |
| VM83-7441X | In distribution | |
| VM82-6541 | In distribution | |
| VM83-3271 | In distribution | |
| VM82-6551 | In distribution | |
| VM82-6510 | In distribution | |
| VM82-64175 | In distribution | |
| VM83-2225 | In distribution | |
| VM81-8766 | In distribution | |
| VM82-6381 | In distribution | |
| VM81-8729 | In distribution | |
| VM83-7427 | In distribution | |
| VM82-6210 | In distribution | |
| VM82-7425 | In distribution | |
| VM82-6477 | In distribution | |
| VM82-6226 | In distribution | |
| VM82-6446 | In distribution | |
| VM81-8739 | In distribution | |
| VM82-6444 | In distribution | |
| VM82-62135 | In distribution | |
| VM82-5089 | In distribution | |
| VM82-5157 | In distribution | |
| VM81-8721 | In distribution | |
| VM81-8738 | In distribution | |
| VM81-8798 | In distribution | |
| VM82-6220 | In distribution | |
| VM82-6205 | In distribution | |
| VM101-4091 | In distribution | |
| VM82-6249 | In distribution | |
| VM82-6218 | In distribution | |
| VM81-8764 | In distribution | |
| VM81-8784 | In distribution | |
| VM83-7461 | In distribution | |
| VM82-6486 | In distribution | |
| VM82-64525 | In distribution | |
| VM82-6427 | In distribution | |
| VM82-62285 | In distribution | |
| VM82-62275 | In distribution | |
| VM81-8754 | In distribution | |
| VM81-8753 | In distribution | |
| VM81-8720 | In distribution | |
| VM82-7220 | In distribution | |
| VM82-7214 | In distribution | |
| VM82-62205 | In distribution | |
| VM83-7426 | In distribution | |
| VM82-62165 | In distribution | |
| VM81-8736 | In distribution | |
| VM83-9681 | In distribution | |
| VM81-8704 | In distribution | |
| VM82-62255 | In distribution | |
| VM82-6461 | In distribution | |
| VM83-3276 | In distribution | |
| VM82-62245 | In distribution | |
| VM82-7218 | In distribution | |
| VM82-6476 | In distribution | |
| VM82-62195 | In distribution | |
| VM82-62125 | In distribution | |
| VM82-6233 | In distribution | |
| VM81-8722 | In distribution | |
| VM81-8783 | In distribution | |
| VM81-8756 | In distribution | |
| VM82-6562 | In distribution | |
| VM82-62105 | In distribution | |
| VM82-7416 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 759 |
| Ambler Surgical | Ambler Surgical, LLC | 456 |
| Spetzler MacroVac® | PMT Corp. | 405 |
| Boss Instruments | Boss Instruments, Ltd. | 311 |
| Dissector | KLS-Martin L.P. | 281 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 229 |
| Macrovac® | PMT Corp. | 190 |
| Millennium | Avalign Technologies, Inc. | 173 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 170 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 168 |
| V. Mueller | Steris Corporation | 156 |
| PMT® Suction Instruments | PMT Corp. | 106 |
Showing 12 of 114. All products under Instrument, Microsurgical
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.