NovoFine® 32G Tip

FDA UDI

Class II (US FDA UDI)

by Novo Nordisk Inc.

Identity

Trade Name: NovoFine® 32G Tip FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: NovoFine® 32G Tip is a sterile disposable needle. FDA UDI
Model / Reference: 185189 FDA UDI
Description: NovoFine® 32G Tip is a sterile disposable needle. FDA UDI

Identifiers

Catalog Number: 185189 FDA UDI
Primary DI / UDI-DI: 00301691851897 FDA UDI
510(k) Number: K090111 FDA UDI
K173479 FDA UDI
K210258 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle 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

FDA UDI

Dimensions & Sizes

Size: Length — 6 Millimeter FDA UDI
Needle Gauge — 32 Gauge FDA UDI

Category: Autoinjector needle

NovoFine® 32G Tip by Novo Nordisk Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Autoinjector needle.

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droplet®, pen needles — HTL STREFA S A · Class II
Nano 2nd Gen — embecta Medical II LLC · Class II
BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II

Cleared under the same submission

K090111 also covers:

NovoFine® 32G Tip — NOVO NORDISK INC.

K173479 also covers:

NovoFine® 32G Tip — NOVO NORDISK INC.

K210258 also covers:

NovoFine® 32G Tip — NOVO NORDISK INC.

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: Novo Nordisk Inc.

Sources (1)

FDA UDI 229914a2-4937-4dd3-984f-aa722fb01fb0 37 fields · synced Jun 1, 2026