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Needle Kit, TargetScan 3, 18 Gauge, Single
FDA UDIClass II (US FDA UDI)
by Best Nomos
Identity
- Trade Name
- Needle Kit, TargetScan 3, 18 Gauge, Single FDA UDI
- Generic Name
- Prostate biopsy needle FDA UDI
- Device Name
- The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan. FDA UDI
- Model / Reference
- 015-A237 FDA UDI
- Description
- The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852656007465 FDA UDI
- 510(k) Number
- K073399 FDA UDI
- FDA Product Code
- ITX FDA UDIFCG FDA UDI
- GMDN Term
- Prostate biopsy needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI876.1075 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
Category: Prostate biopsy needle
Needle Kit, TargetScan 3, 18 Gauge, Single by Best Nomos — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Automatic Cutting Needle — REMINGTON MEDICAL, INC. · Class II
Cleared under the same submission
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
- Best Nomos
Sources (1)
- FDA UDI 9e5a5de9-803a-4c75-bdf3-952aab4e0b66 35 fields · synced Jun 8, 2026