Closed Needle Guide

FDA UDI

Class II (US FDA UDI)

by Remington Medical, Inc.

Identity

Trade Name: Closed Needle Guide FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: 20/22ga (0.9/0.7mm) FDA UDI
Model / Reference: LNGC-2022 FDA UDI
Description: 20/22ga (0.9/0.7mm) FDA UDI

Identifiers

Catalog Number: LNGC-2022 FDA UDI
Primary DI / UDI-DI: 00813079020417 FDA UDI
510(k) Number: K983621 FDA UDI
FDA Product Code: IZH FDA UDI
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1710 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

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

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 22 Gauge FDA UDI

Category: Needle guide, single-use

Closed Needle Guide by Remington Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Needle guide, single-use.

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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

Cleared under the same submission

K983621 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: Remington Medical, Inc.

Sources (1)

FDA UDI 3044c33e-f4f1-4a90-8598-d0a8241c0ba7 37 fields · synced Jun 8, 2026