SurgiLav
Plus Handpiece with Suction Tubing and Multiple-Orifice Tip with Small Soft Cone
17manufacturers in China registered for this device type
13catalogue numbers in this listing
1510(k) clearance
9recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Beijing (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Shenzhen Relish Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Showing 12 of 17. All 17 manufacturers in China registered for Lavage, Jet
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FQH |
| Device type | Lavage, Jet |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5475 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2020-11-06 (version 4) |
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 |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH |
| Packaging | Pack of 6 |
| Sizes | Length 10 ft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0207561000 | In distribution | |
| 0207590000 | In distribution | |
| 0207589000 | In distribution | |
| 0207560000 | In distribution | |
| 0207583000 | In distribution | |
| 0207580000 | Length 10.0 ft | In distribution |
| 0207558000 | In distribution | |
| 0207555000 | In distribution | |
| 0207586000 | Length 10.0 ft | In distribution |
| 0207050000 | In distribution | |
| 0207553000 | In distribution | |
| 0207564000 | In distribution | |
| 0207559000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 65 |
| InterPulse | Stryker GmbH | 41 |
| Lavage, Jet | Stryker GmbH | 40 |
| Pulsavac® | Zimmer Orthopaedic Surgical Products | 35 |
| MicroAire® | Microaire Surgical Instruments LLC | 34 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 32 |
| Simpulse | Davol Inc. | 31 |
| AWI | Apex (Suzhou) Medical Products Company | 27 |
| CarboJet® CO2 Bone Lavage System | Kinamed, Inc. | 26 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 20 |
| Erbe | Erbe Elektromedizin GmbH | 18 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 18 |
Showing 12 of 98. All products under Lavage, Jet
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K873466 | 1987-11-06 |
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 |
|---|---|---|---|---|---|
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 5988 | 2019-04-16 |
| 2015-05-08 | Class II | Package design/selection | Potential sterility breach in the packaging. | 5,328 each (444 boxes) | 2015-10-19 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 330 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 490 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 103 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 470 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 490 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 954 | 2011-06-06 |
| 2010-10-04 | Not classified | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. | 350 | 2011-06-06 |
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.