Identity
- Trade Name
- Magicore Ratchet Driver FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Model / Reference
- MRMDNEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039382366 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Magicore Ratchet Driver by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
Sources (1)
- FDA UDI cc2f9204-8326-4396-9398-8b0e9abaca6e 32 fields · synced May 31, 2026