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, 13G x 17.1 cm. FDA UDI
Model / Reference: SG13-171 FDA UDI
Description: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm. FDA UDI

Identifiers

Catalog Number: SG13-171 FDA UDI
Primary DI / UDI-DI: 07350031351231 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 — 17.1 Centimeter FDA UDI
Needle Gauge — 13 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

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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Apriomed AB

Sources (1)

FDA UDI 7e21f212-aa3b-493c-a560-b9d1bc419ac5 38 fields · synced May 30, 2026