NovoFine® Plus 32G

FDA UDI

Class II (US FDA UDI)

by Novo Nordisk Inc.

Identity

Trade Name: NovoFine® Plus 32G FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. FDA UDI
Model / Reference: 185650 FDA UDI
Description: NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. FDA UDI

Identifiers

Catalog Number: 185650 FDA UDI
Primary DI / UDI-DI: 00301691856502 FDA UDI
510(k) Number: K133738 FDA UDI
K202005 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: Needle Gauge — 32 Gauge FDA UDI
Length — 4 Millimeter FDA UDI

Category: Autoinjector needle

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

Similar devices

Also classified as Autoinjector needle.

Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
MICRON, droplet pen needle — HTL STREFA S A · Class II
SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
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

K133738 also covers:

K202005 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Novo Nordisk Inc.

Sources (1)

FDA UDI f6975f80-32bd-4825-aece-d7d2b82dfaf8 37 fields · synced May 30, 2026