Identity
- Trade Name
- MEDINAUT MAX FDA UDI
- Generic Name
- Multi-purpose surgical power tool system, rechargeable battery-powered FDA UDI
- Device Name
- MEDINAUT MAX Reamer Attachment FDA UDI
- Model / Reference
- BMA-R10 FDA UDI
- Description
- MEDINAUT MAX Reamer Attachment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038053045 FDA UDI
- FDA Product Code
- KIJ FDA UDI
- GMDN Term
- Multi-purpose surgical power tool system, rechargeable battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Medinaut Max by Imedicom Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI 4ea0d23c-133b-4459-9c14-8f7ff2b7f8c2 34 fields · synced May 31, 2026