Zhushi

FDA UDI

Class II (US FDA UDI)

by Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office

Identity

Trade Name: ZHUSHI FDA UDI
Generic Name: General-purpose syringe/needle FDA UDI
Model / Reference: 3mL 0.6mm(23G)×38mmTWLB Luer-lock FDA UDI

Identifiers

Primary DI / UDI-DI: 06941917805378 FDA UDI
510(k) Number: K212033 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
GMDN Term: General-purpose syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose syringe/needle

Zhushi by Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office

Sources (1)

FDA UDI ed33b4b5-e275-48e1-906a-da3ab4cbe1ee 33 fields · synced May 29, 2026