embecta Insulin Syringe

FDA UDI

Class II (US FDA UDI)

by embecta Medical II LLC

Identity

Trade Name: embecta Insulin Syringe FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL FDA UDI
Model / Reference: 329465 FDA UDI
Description: embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL FDA UDI

Identifiers

Catalog Number: 329465 FDA UDI
Primary DI / UDI-DI: 10383017946514 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 28 Gauge FDA UDI
Length — 12.7 Millimeter FDA UDI

Category: Insulin syringe/needle, basic

embecta Insulin Syringe by embecta Medical II LLC — 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: embecta Medical II LLC

Sources (1)

FDA UDI 6d3eed88-4de0-4292-bdbf-6aacbad36615 35 fields · synced Jun 9, 2026