Identity
- Trade Name
- Navigated Biopsy Needle, GPS FDA UDI
- Generic Name
- Brain biopsy procedure kit FDA UDI
- Device Name
- Globus Brain Biopsy Needle FDA UDI
- Model / Reference
- 6143.1828S FDA UDI
- Description
- Globus Brain Biopsy Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212024375 FDA UDI
- 510(k) Number
- K143241 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Brain biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Brain biopsy procedure kit
The Navigated Biopsy Needle, GPS is a cutting-edge medical device designed for minimally invasive neurological procedures. With its unique navigation system and GPS technology, this device provides accurate and reliable sample collection, allowing healthcare professionals to make informed decisions about patient care.
Similar devices
Also classified as Brain biopsy procedure kit.
- Disposable Biopsy Needle — Pajunk GmbH Medizintechnologie · Class II
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp. · Class II
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp. · Class II
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp. · Class II
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K143241 also covers:
- 7D Navigated Brain Biopsy Needle — IZI MEDICAL PRODUCTS LLC
- MDT NAVIGATED BIOPSY, COMPATIABLE 7D — IZI MEDICAL PRODUCTS LLC
- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC
- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC
- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC
- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC
- STRYKER NAVIGATED BIOPSY NEEDLE — IZI MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI ea3a443d-5816-478e-a370-e0f0a2dc21c9 34 fields · synced Jul 22, 2026