Identity
- Trade Name
- Disposable Brain Biopsy Needle Kit FDA UDI
- Generic Name
- Brain biopsy procedure kit FDA UDI
- Model / Reference
- DBN-08-24X FDA UDI
Identifiers
- Catalog Number
- DBN-08-24X FDA UDI
- Primary DI / UDI-DI
- 00841823100948 FDA UDI
- 510(k) Number
- K924348 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
Category: Brain biopsy procedure kit
Disposable Brain Biopsy Needle Kit by Ad-Tech Medical Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Brain biopsy procedure kit.
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- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC · Class II
- Navigated Brain Biopsy Cannula — IZI MEDICAL PRODUCTS LLC · Class II
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- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K924348 also covers:
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
- Disposable Brain Biopsy Needle Kit — Ad-Tech Medical Instrument Corp.
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
- Ad-Tech Medical Instrument Corp.
Sources (1)
- FDA UDI b4cbd34f-30f7-4875-9941-6f38ba9d941e 36 fields · synced Jun 9, 2026