STERiJECT TM

FDA UDI

Class II (US FDA UDI)

by Tsk Laboratory, Japan

Identity

Trade Name: STERiJECT TM FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: TSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI
Model / Reference: PRE-27013N FDA UDI
Description: TSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 04571225315430 FDA UDI
510(k) Number: K970370 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 0.4 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI

Category: Hypodermic needle, single-use

STERiJECT TM by Tsk Laboratory, Japan — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypodermic needle, single-use.

Monoject — Cardinalhealth · Class II
Pinpoint GT — Bard Access Systems, Inc. · Class II
Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
Comfort EZ Pro — S.D.I. USA, INC. · Class II
Jelco — ICU MEDICAL, INC. · 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: Tsk Laboratory, Japan

Sources (1)

FDA UDI 5493ae95-c297-47f3-966a-6c6594284a6a 35 fields · synced Jun 8, 2026