Identity
- Trade Name
- POWEREASE™ Instruments FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- DRILL BIT G2345035S 3.5MM DRILL BIT FDA UDI
- Model / Reference
- G2345035S FDA UDI
- Description
- DRILL BIT G2345035S 3.5MM DRILL BIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994952042 FDA UDI
- 510(k) Number
- K111520 FDA UDI
- FDA Product Code
- HWE FDA UDIGWF FDA UDIHBE FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.1870 FDA UDI882.4310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Fluted surgical drill bit, single-use
POWEREASE™ Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111520 also covers:
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.
- POWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 109b3142-ae87-40d7-bac4-8d52c6e88aed 36 fields · synced May 30, 2026