Perineologic

FDA UDI

Class II (US FDA UDI)

by Corbin Clinical Resources, Llc

Identity

Trade Name: Perineologic FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance. FDA UDI
Model / Reference: 1 FDA UDI
Description: The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance. FDA UDI

Identifiers

Primary DI / UDI-DI: B371P10020 FDA UDI
FDA Product Code: ITX FDA UDI
FCG FDA UDI
GMDN Term: Needle guide, single-use 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Category: Needle guide, single-use

Perineologic by Corbin Clinical Resources, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, single-use.

Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
Sterile transrectal needle guide with sheath — Exact Imaging · Class II
Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · 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: Corbin Clinical Resources, Llc

Sources (1)

FDA UDI 051b10ff-32ec-43f4-8b79-0f410de53800 35 fields · synced May 30, 2026