Identity
- Trade Name
- CORE FDA UDI
- Generic Name
- Bone/joint surgical power tool motor, electric FDA UDI
- Device Name
- Micro Drill FDA UDI
- Model / Reference
- 5400015000 FDA UDI
- Description
- Micro Drill FDA UDI
Identifiers
- Catalog Number
- 5400-015-000 FDA UDI
- Primary DI / UDI-DI
- 04546540401939 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Bone/joint surgical power tool motor, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Core by Stryker Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 50d53ceb-f01e-4733-91fa-9c12e11f74ab 37 fields · synced May 31, 2026