Sklar
Censitrac Ready Davis Brain Spatula 13MM 7 Inches
12manufacturers in China registered for this device type
29catalogue numbers in this listing
1recall
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 | Sklar Corporation, 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 | 2019-05-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-4427 | In distribution | |
| 50-4410 | In distribution | |
| 55-7087 | In distribution | |
| 50-4452C | In distribution | |
| 50-4431 | In distribution | |
| 50-4429 | In distribution | |
| 50-4433 | In distribution | |
| 55-7086 | In distribution | |
| 50-4452 | In distribution | |
| 50-4440 | In distribution | |
| 50-4425 | In distribution | |
| 50-4453C | In distribution | |
| 50-4432 | In distribution | |
| 50-4424 | In distribution | |
| 50-4436 | In distribution | |
| 50-4422 | In distribution | |
| 50-4451 | In distribution | |
| 50-4450 | In distribution | |
| 50-4423 | In distribution | |
| 50-4421 | In distribution | |
| 50-4435 | In distribution | |
| 50-4434 | In distribution | |
| 50-4420 | In distribution | |
| 55-7099C | In distribution | |
| 50-4426 | In distribution | |
| 50-4430 | In distribution | |
| 50-4451C | In distribution | |
| 50-4450C | In distribution | |
| 50-4428 | In distribution |
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 |
| 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
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 |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 25 units |
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.