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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 of drugs, including insulin, GLP-1 analogs, and somatropin. FDA UDI
Model / Reference
185651 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 of drugs, including insulin, GLP-1 analogs, and somatropin. FDA UDI

Identifiers

Catalog Number
185651 FDA UDI
Primary DI / UDI-DI
00301691856519 FDA UDI
510(k) Number
K133738 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 32 Gauge FDA UDI
Length — 4 Millimeter FDA UDI

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

Cleared under the same submission

K133738 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Nordisk Inc.

Sources (1)

  • FDA UDI 328afccf-58f2-40b3-ba20-518a0b1fcb80 38 fields · synced May 30, 2026