Identity
- Trade Name
- Ventriculostomy Kit - European FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- KIT 46154 VNTRC EURO FDA UDI
- Model / Reference
- 46154 FDA UDI
- Description
- KIT 46154 VNTRC EURO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673978947396 FDA UDI
- 510(k) Number
- K915546 FDA UDI
- FDA Product Code
- HBG FDA UDI
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4300 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
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
No
FDA UDI
Category: Manual surgical rotary handpiece, reusable
Ventriculostomy Kit - European by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual surgical rotary handpiece, reusable.
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Cleared under the same submission
K915546 also covers:
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
- Medtronic PS Medical
Sources (1)
- FDA UDI 900507d1-6ab7-4d6d-a26d-a5d8f705c543 35 fields · synced May 30, 2026