Flexicare
Reusable Fiber Optic Box Set Standard Rough Handle + Blades Miller 00, 0, 1, 2, 3 & 4
44manufacturers in China registered for this device type
42catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid
Record
| Listed by | Flexicare Medical Ltd., United Kingdom |
|---|---|
| FDA product code | CCW |
| Device type | Laryngoscope, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5540 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-04 |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 040-852U | In distribution | |
| 040-833U | In distribution | |
| 040-822U | In distribution | |
| 040-924U | In distribution | |
| 040-12-0130U | In distribution | |
| 040-835U | In distribution | |
| 040-930U | In distribution | |
| 041-601U | In distribution | |
| 040-931U | In distribution | |
| 040-849U | In distribution | |
| 040-824U | In distribution | |
| 040-823U | In distribution | |
| 040-12-2135U | In distribution | |
| 040-821U | In distribution | |
| 041-402U | In distribution | |
| 040-862U | In distribution | |
| 040-854U | In distribution | |
| 040-850U | In distribution | |
| 040-851U | In distribution | |
| 040-874U | In distribution | |
| 040-11-0000U | In distribution | |
| 040-860U | In distribution | |
| 040-861U | In distribution | |
| 040-12-2130U | In distribution | |
| 040-891U | In distribution | |
| 040-892U | In distribution | |
| 040-853U | In distribution | |
| 040-831U | In distribution | |
| 040-880U | In distribution | |
| 040-832U | In distribution | |
| 040-952U | In distribution | |
| 040-922U | In distribution | |
| 040-921U | In distribution | |
| 040-894U | In distribution | |
| 040-923U | In distribution | |
| 040-893U | In distribution | |
| 040-12-2140U | In distribution | |
| 040-834U | In distribution | |
| 040-12-0140U | In distribution | |
| 040-951U | In distribution | |
| 040-836U | In distribution | |
| 041-401U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 509 |
| SunMed | SunMed Group Holdings, LLC | 255 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| AincA® | Anesthesia Associates, Inc. | 186 |
| Curaplex | Bound Tree Medical, LLC | 172 |
| GlideScope® | Verathon Medical (Canada) ULC | 166 |
| Pilling | Teleflex Medical LLC | 163 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 157 |
| Laryngoscope, Rigid | Karl Storz GmbH & Co. KG | 140 |
| Medline | Medline Industries, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 111 |
| Sklar® | Sklar Corporation | 92 |
Showing 12 of 442. All products under Laryngoscope, Rigid
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 |
|---|---|---|---|---|---|
| 2019-11-27 | Class II | Nonconforming Material/Component | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient’s mount it is a possibility that any loos | 1,024,890 devices | 2021-04-27 |
| 2019-11-27 | Class II | Nonconforming Material/Component | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient’s mount it is a possibility that any loos | 1,024,890 devices | 2021-04-27 |
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.