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Urocore

FDA UDI

Class I (US FDA UDI)

by H.s. Hospital Service Spa

Identity

Trade Name
UROCORE FDA UDI
Generic Name
Prostate biopsy needle FDA UDI
Device Name
UROCORE 14GX115MM FDA UDI
Model / Reference
UROCORE FDA UDI
Description
UROCORE 14GX115MM FDA UDI

Identifiers

Catalog Number
UC 14115 FDA UDI
Primary DI / UDI-DI
08033003348291 FDA UDI
FDA Product Code
GAA FDA UDI
GMDN Term
Prostate biopsy needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 14 Gauge FDA UDI
Length — 115 Millimeter FDA UDI

Category: Prostate biopsy needle

Urocore by H.s. Hospital Service Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prostate biopsy needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H.s. Hospital Service Spa

Sources (1)

  • FDA UDI ae2177a5-3f15-4ec8-9966-023c029642b2 36 fields · synced Jun 6, 2026