Medinaut MAX
MEDINAUT MAX Drill Universal Type Attachment
10manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (1), Guangdong (1). 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Imedicom Co., Ltd., South Korea |
|---|---|
| FDA product code | KIJ |
| Device type | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-01-12 |
| Record revised | 2023-11-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 40 °C; Handling environment humidity 10 to 75 % RH |
| Distribution end date | 2023-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC400D | In distribution | |
| BHC-400 | In distribution | |
| BMA-D20-AP01 | In distribution | |
| BC400 | In distribution | |
| BMK-200 | In distribution | |
| BHL-400 | In distribution | |
| BMK-100 | In distribution | |
| BSC-400 | In distribution | |
| BMA-P10 | Withdrawn | |
| BMA-D20 | Withdrawn | |
| BMA-D20-AP01 | Withdrawn | |
| BMA-T10-W | Withdrawn | |
| BMA-S10 | Withdrawn | |
| BMA-W10 | Withdrawn | |
| BMA-D40 | Withdrawn | |
| BMA-D30 | Withdrawn | |
| BMA-D10 | Withdrawn | |
| BMA-R30 | Withdrawn | |
| BMA-T10 | Withdrawn | |
| BMH-200 | Withdrawn | |
| BMA-R20 | Withdrawn | |
| BMA-R10 | Withdrawn | |
| BMA-P10-G | Withdrawn | |
| BMH-100 | Withdrawn | |
| BMA-C10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stainless Steel Guide Wires | Orthopediatrics, Corp | 76 |
| OsteoMed | Osteomed | 36 |
| CS2 Acetabular System | Shalby Advanced Technologies, Inc. | 32 |
| MicroAire® | Microaire Surgical Instruments LLC | 20 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 18 |
| Pediatric Nailing Platform | Tibia | Orthopediatrics, Corp | 17 |
| PNP Tibia | Orthopediatrics, Corp | 14 |
| EZImpactor | Imedicom Co., Ltd. | 13 |
| Insurgical, Inc. | Insurgical, Inc. | 12 |
| Response Spine System | Orthopediatrics, Corp | 12 |
| 3P Hip System | Orthopediatrics, Corp | 12 |
| Global Steptech | Depuy (Ireland) | 12 |
Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
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.