GEN2
DBX Micro Spatula Medium True Balance Ceramic 7.5"
12manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Surgix Medical LLC, United States |
|---|---|
| FDA product code | GAF |
| Device type | Spatula, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-25 |
| Record revised | 2025-06-17 (version 2) |
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 |
| Sizes | Length 7.5 to 12.5 in; length 21 cm; width 10 to 30 mm; length 210 mm |
| Distribution end date | 2025-06-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2N95660 | Length 210 mm | In distribution |
| G2N95661 | Length 210 mm | In distribution |
| G2N95667 | Length 21 cm | In distribution |
| G2N49308 | Length 7.5 in | In distribution |
| G2N49306 | Length 7.5 in | In distribution |
| G2DB7003 | Length 7.5 in | In distribution |
| G2N7003 | Length 7.5 in | In distribution |
| G2DB7002 | Length 7.5 in | In distribution |
| G2N49307 | Length 7.5 in | In distribution |
| G2DB7052 | In distribution | |
| G2N95665 | Length 21 cm | In distribution |
| G2N88857 | Length 8.5 in | In distribution |
| G2N95660 | Length 210 mm | In distribution |
| G2N7001 | Length 7.5 in | In distribution |
| G2N7002 | Length 7.5 in | In distribution |
| G2N95668 | Length 21 cm | In distribution |
| G2DB7051 | In distribution | |
| G2N95666 | Length 21 cm | In distribution |
| G2N95668 | Length 21 cm | In distribution |
| G2N95665 | Length 21 cm | In distribution |
| G2N95666 | Length 21 cm | In distribution |
| G2N95662 | Length 210 mm | In distribution |
| G2DB7053 | In distribution | |
| G2N95661 | Length 210 mm | In distribution |
| G2N95662 | Length 210 mm | In distribution |
| G2C62410 | Length 12.5 in | In distribution |
| G2DB7001 | Length 7.5 in | In distribution |
| G2N95667 | Length 21 cm | In distribution |
| G2DB7051 | Withdrawn | |
| G2DB7053 | Withdrawn | |
| G2N7002 | Length 7.5 in | Withdrawn |
| G2DB7052 | Withdrawn | |
| G2N7003 | Length 7.5 in | Withdrawn |
| G2N7001 | Length 7.5 in | 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 |
| 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 |
| Henry Schein | Henry Schein, Inc. | 18 |
Showing 12 of 93. All products under Spatula, Surgical, General & Plastic Surgery
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.