Needle Kit, TargetScan 2, 18 Gauge, Single

FDA UDI

Class II (US FDA UDI)

by Best Nomos

Identity

Trade Name: Needle Kit, TargetScan 2, 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 the Targetscan System to target the prostate biopsy locations created in a biopsy plan. FDA UDI
Model / Reference: 015-A200 FDA UDI
Description: The TargetScan needles are used in conjunction with the biopsy planning feature of the Targetscan System to target the prostate biopsy locations created in a biopsy plan. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852656007441 FDA UDI
510(k) Number: K073399 FDA UDI
FDA Product Code: ITX FDA UDI
FCG FDA UDI
GMDN Term: Prostate biopsy needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Prostate biopsy needle

Needle Kit, TargetScan 2, 18 Gauge, Single by Best Nomos — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Prostate biopsy needle.

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Cleared under the same submission

K073399 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: Best Nomos

Sources (1)

FDA UDI 4f7693b1-112e-4240-8476-60886e452aff 35 fields · synced May 30, 2026