Syringe 3ml

FDA UDI

Class II (US FDA UDI)

by Geri-Gentle Corporation

Identity

Trade Name: Syringe 3ml FDA UDI
Generic Name: Anaesthesia Luer syringe FDA UDI
Device Name: Syringe 3ml FDA UDI
Model / Reference: 11-300 FDA UDI
Description: Syringe 3ml FDA UDI

Identifiers

Primary DI / UDI-DI: 00369771001785 FDA UDI
510(k) Number: K113091 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Anaesthesia Luer syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Category: Anaesthesia Luer syringe

Syringe 3ml by Geri-Gentle Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia Luer syringe.

Shifeng — Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. · Class II
Shifeng — Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. · Class II

Cleared under the same submission

K113091 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: Geri-Gentle Corporation

Sources (1)

FDA UDI 166a464e-0076-4a7b-86dd-7f87ba7dc01f 34 fields · synced Jun 1, 2026