FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEDINAUT MAX
DI: 08800038053007
·
Model: BMH-100
·
IMEDICOM CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDINAUT MAX
- Primary DI
- 08800038053007
- Version / Model
- BMH-100
- Company Name
- IMEDICOM CO., LTD.
- Labeler DUNS
- 690340653
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-22
- Public Version
- 1
- Public Version Date
- 2021-11-01
- Public Version Status
- New
- Public Device Record Key
- fe10247c-d322-4ef7-83a2-0a28e0d9fc19
- Distribution End Date
- 2021-10-22
Device Description
MEDINAUT MAX Handpiece
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44641 | Multi-purpose surgical power tool system, rechargeable battery-powered | An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800038053007 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity