InvisiGrip Vein Stripper
Catalogue number 1500-01, listed by Lemaitre Vascular, Inc., United States, under Spatula, Surgical, General & Plastic Surgery. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Hebei (3), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Lemaitre Vascular, Inc., United States |
|---|---|
| FDA product code | GAF |
| Device type | Spatula, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| 510(k) | K023688 |
| Record published | 2015-06-30 |
| Record revised | 2021-04-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1500-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 131 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 84 |
| Aesculap | Aesculap AG | 59 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 45 |
| GEN2 | Surgix Medical LLC | 34 |
| Lazic | Peter Lazic Gmbh | 33 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 31 |
| Sklar | Sklar Corporation | 29 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 22 |
| Spatula, Surgical, General & Plastic Surgery | Fehling Instruments GmbH | 21 |
| Symmetry Davis | Aspen Surgical Products, Inc. | 19 |
| Spatula | KLS-Martin L.P. | 19 |
Showing 12 of 93. All products under Spatula, Surgical, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023688 | 2003-01-30 |
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.