Identity
- Trade Name
- Bone Management FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Micro Screw System FDA UDI
- Model / Reference
- BMS00 FDA UDI
- Description
- Micro Screw System FDA UDI
Identifiers
- Catalog Number
- BMS00 FDA UDI
- Primary DI / UDI-DI
- E0HM79BMS001 FDA UDI
- 510(k) Number
- K201210 FDA UDI
- FDA Product Code
- GFF FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Bone Management by Hager & Meisinger Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
K201210 also covers:
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
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
Sources (1)
- FDA UDI 80f6f7ec-2924-46c1-ba1b-a799e67c4e12 36 fields · synced May 31, 2026