Erbe
ERBEJET® 2 two pedal footsw. w/ReMode; AP & IP X8 Equipment
17manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | Erbe Elektromedizin GmbH, Germany |
|---|---|
| FDA product code | FQH |
| Device type | Lavage, Jet |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5475 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K072404 |
| Record published | 2016-12-22 |
| 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, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from heat and direct sunlight; Special storage condition: Keep dry |
| Packaging | Level: 1 of 5, pack of 5 |
| Sizes | Length 65 to 336 mm; outer diameter 6 mm; length 2.2 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20325-101 | In distribution | |
| 20150-241 | Length 90.000 mm | In distribution |
| 10325-000 | In distribution | |
| 20150-239 | Length 180.000 mm | In distribution |
| 10150-000 | In distribution | |
| 20150-103 | In distribution | |
| 20325-100 | In distribution | |
| 20150-236 | Outer Diameter 6.000 mm | In distribution |
| 20150-238 | Length 306.000 mm | In distribution |
| 20150-220 | Length 2.200 m | In distribution |
| 20150-226 | Length 336.000 mm | In distribution |
| 20150-225 | Length 183.000 mm | In distribution |
| 20150-231 | Length 65.000 mm | In distribution |
| 20150-300 | In distribution | |
| 20150-102 | In distribution | |
| 20150-301 | In distribution | |
| 10340-000 | In distribution | |
| 20150-230 | Length 65.000 mm | 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 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 18 |
| debritom+ | Medaxis AG | 17 |
Showing 12 of 98. All products under Lavage, Jet
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231023 | 2023-06-15 |
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.