3m™
3M™ Surgical Clipper Starter Kit (9661L Clipper and 9668L Charger Stand) 9667L-E
34manufacturers in China registered for this device type
24catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (12), Zhejiang (10), Jiangsu (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zhejiang Beauty AND Health Electrical Appliance Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Raymond (Panyu Nansha) Electrical Appliances Development Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Ningbo Kaili Holding Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 34. All 34 manufacturers in China registered for Razor, Surgical
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | LWK |
| Device type | Razor, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case, box of 5, case of 4, box of 2, each of 4, pack of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9667L | In distribution | ||
| 9661L | In distribution | ||
| 9660 | 10 | In distribution | |
| 9682 | In distribution | ||
| 9661L | In distribution | ||
| 9681 | In distribution | ||
| 9667L | In distribution | ||
| 9600 | 40 | In distribution | |
| 9680 | 10 | In distribution | |
| 9600 | 10 | In distribution | |
| 9660 | 50 | In distribution | |
| 9690 | 10 | In distribution | |
| 9667L-E | In distribution | ||
| 9690 | 20 | In distribution | |
| 9681 | In distribution | ||
| 9667L-A | In distribution | ||
| 9662L | In distribution | ||
| 9662L | In distribution | ||
| 9681 | In distribution | ||
| 9661L | In distribution | ||
| 9602 | In distribution | ||
| 9681 | In distribution | ||
| 9680 | 10 | In distribution | |
| 9667L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Juliet ® Instrumentation | Spineart SA | 29 |
| Solventum™ | Solventum US LLC | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
| DeRoyal | Deroyal Industries, Inc. | 5 |
| Romeo posterior osteosynthesis system | Spineart SA | 4 |
| Razor, Surgical | Carefusion 2200, Inc. | 4 |
| Medline | Medline Industries, Inc. | 4 |
| SourceMark | Sourcemark, LLC. | 4 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Twin Blade Razors | Dynarex Corp. | 1 |
| DawnMist | Dukal LLC | 1 |
| AMSafe® Prep Razor | Amsino Medical Inc. | 1 |
Showing 12 of 23. All products under Razor, Surgical
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 3M Company | UDI-DI | 2024-01-12 | Class II | Under Investigation by firm | 3M has added the following cautionary statement regarding the use of the product: “Caution – To reduce the risk of burns, which if not avoided may result in minor injury: “ Do not use on injured skin. “ Do not leave clipper running unused | 52,833,750 blades |
| 3M Company | UDI-DI | 2024-01-12 | Class II | Under Investigation by firm | 3M has added the following cautionary statement regarding the use of the product: “Caution – To reduce the risk of burns, which if not avoided may result in minor injury: “ Do not use on injured skin. “ Do not leave clipper running unused | 764,580 blades |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2019-01-14 | Class II | Nonconforming Material/Component | 3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter. | 19,860 units | 2021-02-11 |
| 2018-02-02 | Class II | Labeling design | Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with b | 120000 units | 2024-08-02 |
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.