MicroAire®
34 catalogue numbers from 201-03-00, listed by Microaire Surgical Instruments LLC, United States, under Lavage, Jet. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Microaire Surgical Instruments LLC, United States |
|---|---|
| FDA product code | FQH |
| Device type | Lavage, Jet |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-04 |
| Record revised | 2020-11-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2022-11-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 201-03-00 | In distribution | ||
| 4740-013 | 6 | In distribution | |
| 5740-060 | 6 | In distribution | |
| 201-00-46 | In distribution | ||
| 5740-100 | In distribution | ||
| 201-00-50 | In distribution | ||
| 5740-061S | 6 | In distribution | |
| 4700-015 | 6 | In distribution | |
| 5740-061 | 6 | In distribution | |
| 201-05-00 | In distribution | ||
| 4700-016 | 6 | In distribution | |
| 201-00-51 | In distribution | ||
| 201-02-00 | 6 | In distribution | |
| 201-00-44 | In distribution | ||
| 201-00-52 | In distribution | ||
| 5740-200 | In distribution | ||
| 201-00-37 | In distribution | ||
| 201-00-80 | In distribution | ||
| 5740-600 | In distribution | ||
| 5740-062 | 6 | In distribution | |
| 201-04-00 | In distribution | ||
| 5740-008 | 6 | Withdrawn | |
| 5740-005 | 6 | Withdrawn | |
| 5740-010S | 6 | Withdrawn | |
| 5740-006 | 6 | Withdrawn | |
| 5740-006S | 6 | Withdrawn | |
| 5740-020S | 6 | Withdrawn | |
| 5740-004S | 6 | Withdrawn | |
| 5740-004 | 6 | Withdrawn | |
| 5740-009 | 6 | Withdrawn | |
| 5740-009S | 6 | Withdrawn | |
| 5740-005S | 6 | Withdrawn | |
| 5740-020 | 6 | Withdrawn | |
| 5740-062S | 6 | Withdrawn |
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 |
| 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 |
| debritom+ | Medaxis AG | 17 |
Showing 12 of 98. All products under Lavage, Jet
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.