Gangi-SoftGuard Coaxial Needle

FDA UDI

Class II (US FDA UDI)

by Apriomed AB

Identity

Trade Name: Gangi-SoftGuard Coaxial Needle FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 12G x 12.1 cm. FDA UDI
Model / Reference: SG12-121 FDA UDI
Description: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 12G x 12.1 cm. FDA UDI

Identifiers

Catalog Number: SG12-121 FDA UDI
Primary DI / UDI-DI: 07350031351194 FDA UDI
510(k) Number: K181756 FDA UDI
FDA Product Code: FCG FDA UDI
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 12.1 Centimeter FDA UDI
Needle Gauge — 12 Gauge FDA UDI

Category: Needle guide, single-use

Gangi-SoftGuard Coaxial Needle by Apriomed AB — 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
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InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Cleared under the same submission

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: Apriomed AB

Sources (1)

FDA UDI b3f7c964-2dda-4c34-9953-ba14259c5259 38 fields · synced Jun 8, 2026