Primary Device ID | 08800038055605 |
NIH Device Record Key | e1679621-4b0d-45ba-8db4-1aec2ef2d5f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MEDINAUT MAX Pro |
Version Model Number | BSH-100 |
Company DUNS | 690340653 |
Company Name | IMEDICOM CO., LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800038055605 [Primary] |
KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
[08800038055605]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-23 |
Device Publish Date | 2024-04-15 |
08800038060265 - EZX | 2025-07-25 EZX (EZX Tray) |
08800038060272 - EZX | 2025-07-25 EZX (Tray Cover) |
08800038060289 - EZX | 2025-07-25 EZX (Lower Tray) |
08800038060296 - EZX | 2025-07-25 EZX (Upper Tray) |
08800038060302 - EZX | 2025-07-25 EZX(Main Tray) |
08800038060142 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Trocar type Needle |
08800038060159 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Bevel type Needle |
08800038060166 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Diamond type Needle |