Non-Sterile Reusable Needle Guide - 16GA

FDA UDI

Class II (US FDA UDI)

by Exact Imaging

Identity

Trade Name: Non-Sterile Reusable Needle Guide - 16GA FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer FDA UDI
Model / Reference: EV-BIOG-R16 FDA UDI
Description: Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer FDA UDI

Identifiers

Catalog Number: EV-BIOG-R16 FDA UDI
Primary DI / UDI-DI: 00628055481140 FDA UDI
FDA Product Code: OIJ FDA UDI
GMDN Term: Needle guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Needle guide, reusable

Non-Sterile Reusable Needle Guide - 16GA by Exact Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

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InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
EZU-PA5O-14 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

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: Exact Imaging

Sources (1)

FDA UDI 6c6e1b82-2c30-4323-9a11-2e95a9389ae7 34 fields · synced Jun 1, 2026