Identity
- Trade Name
- Disposable Pre-calibrated Biopsy Needle FDA UDI
- Generic Name
- Brain biopsy procedure kit FDA UDI
- Device Name
- Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm FDA UDI
- Model / Reference
- 42051-01 FDA UDI
- Description
- Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm FDA UDI
Identifiers
- Catalog Number
- 42051-01 FDA UDI
- Primary DI / UDI-DI
- 04048223099018 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 257.0 Millimeter FDA UDIOuter Diameter — 2.1 Millimeter FDA UDI
Category: Brain biopsy procedure kit
Disposable Pre-calibrated Biopsy Needle by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 0115a747-7d7b-4aa5-a809-5bcd4d23cea1 37 fields · synced Jun 6, 2026