Identity
- Trade Name
- 2.0MM SYSTEM FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- DRILL 1.5X105MM 22MM STP J-NT FDA UDI
- Model / Reference
- 01-9198 FDA UDI
- Description
- DRILL 1.5X105MM 22MM STP J-NT FDA UDI
Identifiers
- Catalog Number
- 01-9198 FDA UDI
- Primary DI / UDI-DI
- 00841036016982 FDA UDI
- 510(k) Number
- K062842 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
No
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
Category: Fluted surgical drill bit, reusable
2.0mm System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062842 also covers:
- "1.0MM" SYSTEM TWIST DRILL — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.4MM" FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- "2.4MM" FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 1.5 MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.7MM SYSTEM — BIOMET MICROFIXATION, INC
- LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI 7065eae6-a7d2-4802-9988-5705c3a467e0 36 fields · synced May 29, 2026